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IRCT20220315054296N1 IRCT 2022-04-07 Tehran University of Medical Sciences The effect of written emotional disclosure on the care burden, anxiety and depression of the family caregivers of hemodialysis patients The effect of written emotional disclosure on the care burden, anxiety and depression of the family caregivers of hemodialysis patients 2022-04-30 anticipated 99 Complete https://irct.ir/trial/62508 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This research is a semi-experimental study with two intervention groups and a control group. Since the probability of information pollution is predicted, intervention groups 1 and 2 and control will be selected from three hospitals separately. Initially, 3 Imam Khomeini, Sina and Shariati hospitals will be randomly assigned to groups: first intervention, second intervention and control; Then sampling will be done using convenient method any of in these hospitals. In this way, all qualified caregivers will enter the study. N/A . Intervention 1: Intervention group: The first intervention group: After completing the initial questionnaires, the standard guidelines of written emotional disclosure based on the evidence-based written program from Pennebaker and Beall entitled: 'writing about the most traumatic experience of their entire life other than being a caregiver' will be presented verbally and written to the first intervention group. In order to maintain the adherence of participants to intervene, at the time agreed to start writing sessions, participants will be contacted and reminded to begin their writing session and again they will be contacted in the next two days or SMS Reminder will be sent. Also, caregivers will be requested to take pictures of their writings or if they have typed them, they will be requested to copy their texts and send them for researchers. The aim of this action is maintaining the adherence of the participants to the written intervention and increase their writing power (because they are sure that someone else reads their writings, although there is no direct interaction between participants and researchers about the writings). In addition to sending writings, the first intervention group will be asked to write their opinion and satisfaction of these three sessions and written experience in a paragraph and send it to the researcher. The text of the instruction is as follows: 'You are expected to write at home or place of your choice, within 3 sessions of 20 minutes in 3 consecutive days about the traumatic experience, evolution, stressful event, conflict or psychological problem you are currently facing or you have experienced in another period of your life. It is better that the topic is the one that you have not talked about it to anyone and it still annoys you or thinking about it makes you uncomfortable. You can write about anything you want, but whatever you choose should be something that has deeply affected you. When you write about the event, try to clarify your memories about the experience as possible as you can, including thoughts, feelings and any Physical sense you have experienced. It is important to free yourself and touch the deepest feelings and thoughts you have about this experience. You can also write about the effects of the experience. For example, how it has influenced your self-esteem, relationships and health. Please try to write about a particular event or experience during all three sessions, but this is not a requirement. If you feel that you have solved the stressful experience and it no longer hurts you, you can write about another experience. Time for writing in every session is 20 minutes, and do not worry about spelling, the structure of sentences and grammar, the only rule is that when you start writing, write freely and without trying to write a good story and continue this writing to finish the 20-minute time. In each session after your initial writing, please take time to read your writing again and think about it before starting the next session. After completing every 3 written sessions, take pictures of your writings or if you have typed them, copy the texts and send them to me. You do not need to write your name in the writing and your writings will be completely confidential, and your name and text will not be published somewhere. Also, after the last written session, please generally write your opinion and satisfaction of these three sessions and writing experience in a paragraph and send it to me a separate text '. Intervention 2: Intervention group: The second intervention group: After completing the initial questionnaires, the standard guidelines of written emotional disclosure based on the evidence-based written program from Pennebaker and Beall entitled: 'writing about the stress of being a caregiver' will be presented verbally and written to the second intervention group. In order to maintain the adherence of participants to intervene, at the time agreed to start writing sessions, participants will be contacted and reminded to begin their writing session and again they will be contacted in the next two days or SMS Reminder will be sent. Also, caregivers will be requested to take pictures of their writings or if they have typed them, they will be requested to copy their texts and send them for researchers. The aim of this action is maintaining the adherence of the participants to the written intervention and increase their writing power (because they are sure that someone else reads their writings, although there is no direct interaction between participants and researchers about the writings). In addition to sending writings, the second intervention group will be asked to write their opinion and satisfaction of these three sessions and written experience in a paragraph and send it to the researcher. The text of the instruction is as follows: 'You are expected to write at home or place of your choice, within 3 sessions of 20 minutes in 3 consecutive days about the the stress of being a caregiver. These stress could include traumatic experiences, conflicts or problems caused by caregiving role. It is better that the topic is the one that you have not talked about it to anyone and it still annoys you or thinking about it makes you uncomfortable. You can write about anything you want, but whatever you choose should be something that has deeply affected you and is related to your caregiving role. When you write about the event, try to clarify your memories about the experience as possible as you can, including thoughts, feelings and any Physical sense you have experienced. It is important to free yourself and touch the deepest feelings and thoughts you have about this experience. You can also write about the effects of the stress. For example, how it has influenced your self-esteem, relationships and health. Please try to write about a particular event or experience during all three sessions, but this is not a requirement. If you feel that you have solved the stressful experience and it no longer hurts you, you can write about another experience. Time for writing in every session is 20 minutes, and do not worry about spelling, the structure of sentences and grammar, the only rule is that when you start writing, write freely and without trying to write a good story and continue this writing to finish the 20-minute time. In each session after your initial writing, please take time to read your writing again and think about it before starting the next session. After completing every 3 written sessions, take pictures of your writings or if you have typed them, copy the texts and send them to me. You do not need to write your name in the writing and your writings will be completely confidential, and your name and text will not be published somewhere. Also, after the last written session, please generally write your opinion and satisfaction of these three sessions and writing experience in a paragraph and send it to me a separate text '. Intervention 3: Control group: After completing the initial questionnaires, based on the standard guidelines of written emotional disclosure from Pennebaker and Beall, neutral writing instruction entitled: "Time management" will be presented verbally and written to the control group. In order to maintain the adherence of participants to intervene, at the time agreed to start writing sessions, participants will be contacted and reminded to begin their writing session and again they will be contacted in the next two days or SMS Reminder will be sent. Also, caregivers will be requested to take pictures of their writings or if they have typed them, they will be requested to copy their texts and send them for researchers. The text of the instruction is as follows: 'You are expected to write at home or place of your choice, within 3 sessions of 20 minutes in 3 consecutive days about how you manage your time. The subject will be different in every 3 days: Day 1: You should write in detail about how you spent your time and what you have done during the last week. Day 2: You should write about the works that you have done over the last 24 hours. Day3: You should write in detail about what you intend to do in next 24 hours. When writing, you should try to write the work you have done or your planned actions accurately and avoid writing your feelings or comments on the work done or planned. For example, what activities did you do day by day or hour to hours. The time of writing is 20 minutes and do not worry about spelling, the structure of sentences and grammar, the only rule is to write freely when you start writing, and continue it until 20 minutes. After completing every 3 written sessions, take pictures of your writings or if you have typed them, copy the texts and send them to me. You do not need to write your name in the writing and your writings will be completely confidential, and your name and text will not be published somewhere.'. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I do not have a plan
public Zahra Lotfolahi
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat st. Tohid sq. Tehran I.IRAN
Tehran Iran (Islamic Republic of) 141973317 +98 21 6691 4368 zahra.ltf1998@gmail.com Tehran University of Medical Sciences scientific Dr. Arpi Manookian
School of Nursing Midwifery, Tehran University of Medical Sciences, Nosrat st. Tohid sq. Tehran I.IRAN
Tehran Iran (Islamic Republic of) 141973317 +98 21 6691 4368 ar-manookian@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 to 75 years old Providing care directly to the patient under hemodialysis at least in the past 3 months Speaking in Persian The ability to read and write in Persian Having physical and mental health necessary for caring role Consent to participate in the study Access to smartphone Ability to use smartphone 18 years 75 years Both Simultaneous care of another patient with chronic illness Rehabilitation Rehabilitation Rehabilitation Intervention group: The first intervention group: After completing the initial questionnaires, the standard guidelines of written emotional disclosure based on the evidence-based written program from Pennebaker and Beall entitled: 'writing about the most traumatic experience of their entire life other than being a caregiver' will be presented verbally and written to the first intervention group. In order to maintain the adherence of participants to intervene, at the time agreed to start writing sessions, participants will be contacted and reminded to begin their writing session and again they will be contacted in the next two days or SMS Reminder will be sent. Also, caregivers will be requested to take pictures of their writings or if they have typed them, they will be requested to copy their texts and send them for researchers. The aim of this action is maintaining the adherence of the participants to the written intervention and increase their writing power (because they are sure that someone else reads their writings, although there is no direct interaction between participants and researchers about the writings). In addition to sending writings, the first intervention group will be asked to write their opinion and satisfaction of these three sessions and written experience in a paragraph and send it to the researcher. The text of the instruction is as follows: 'You are expected to write at home or place of your choice, within 3 sessions of 20 minutes in 3 consecutive days about the traumatic experience, evolution, stressful event, conflict or psychological problem you are currently facing or you have experienced in another period of your life. It is better that the topic is the one that you have not talked about it to anyone and it still annoys you or thinking about it makes you uncomfortable. You can write about anything you want, but whatever you choose should be something that has deeply affected you. When you write about the event, try to clarify your memories about the experience as possible as you can, including thoughts, feelings and any Physical sense you have experienced. It is important to free yourself and touch the deepest feelings and thoughts you have about this experience. You can also write about the effects of the experience. For example, how it has influenced your self-esteem, relationships and health. Please try to write about a particular event or experience during all three sessions, but this is not a requirement. If you feel that you have solved the stressful experience and it no longer hurts you, you can write about another experience. Time for writing in every session is 20 minutes, and do not worry about spelling, the structure of sentences and grammar, the only rule is that when you start writing, write freely and without trying to write a good story and continue this writing to finish the 20-minute time. In each session after your initial writing, please take time to read your writing again and think about it before starting the next session. After completing every 3 written sessions, take pictures of your writings or if you have typed them, copy the texts and send them to me. You do not need to write your name in the writing and your writings will be completely confidential, and your name and text will not be published somewhere. Also, after the last written session, please generally write your opinion and satisfaction of these three sessions and writing experience in a paragraph and send it to me a separate text ' Intervention group: The second intervention group: After completing the initial questionnaires, the standard guidelines of written emotional disclosure based on the evidence-based written program from Pennebaker and Beall entitled: 'writing about the stress of being a caregiver' will be presented verbally and written to the second intervention group. In order to maintain the adherence of participants to intervene, at the time agreed to start writing sessions, participants will be contacted and reminded to begin their writing session and again they will be contacted in the next two days or SMS Reminder will be sent. Also, caregivers will be requested to take pictures of their writings or if they have typed them, they will be requested to copy their texts and send them for researchers. The aim of this action is maintaining the adherence of the participants to the written intervention and increase their writing power (because they are sure that someone else reads their writings, although there is no direct interaction between participants and researchers about the writings). In addition to sending writings, the second intervention group will be asked to write their opinion and satisfaction of these three sessions and written experience in a paragraph and send it to the researcher. The text of the instruction is as follows: 'You are expected to write at home or place of your choice, within 3 sessions of 20 minutes in 3 consecutive days about the the stress of being a caregiver. These stress could include traumatic experiences, conflicts or problems caused by caregiving role. It is better that the topic is the one that you have not talked about it to anyone and it still annoys you or thinking about it makes you uncomfortable. You can write about anything you want, but whatever you choose should be something that has deeply affected you and is related to your caregiving role. When you write about the event, try to clarify your memories about the experience as possible as you can, including thoughts, feelings and any Physical sense you have experienced. It is important to free yourself and touch the deepest feelings and thoughts you have about this experience. You can also write about the effects of the stress. For example, how it has influenced your self-esteem, relationships and health. Please try to write about a particular event or experience during all three sessions, but this is not a requirement. If you feel that you have solved the stressful experience and it no longer hurts you, you can write about another experience. Time for writing in every session is 20 minutes, and do not worry about spelling, the structure of sentences and grammar, the only rule is that when you start writing, write freely and without trying to write a good story and continue this writing to finish the 20-minute time. In each session after your initial writing, please take time to read your writing again and think about it before starting the next session. After completing every 3 written sessions, take pictures of your writings or if you have typed them, copy the texts and send them to me. You do not need to write your name in the writing and your writings will be completely confidential, and your name and text will not be published somewhere. Also, after the last written session, please generally write your opinion and satisfaction of these three sessions and writing experience in a paragraph and send it to me a separate text ' Control group: After completing the initial questionnaires, based on the standard guidelines of written emotional disclosure from Pennebaker and Beall, neutral writing instruction entitled: "Time management" will be presented verbally and written to the control group. In order to maintain the adherence of participants to intervene, at the time agreed to start writing sessions, participants will be contacted and reminded to begin their writing session and again they will be contacted in the next two days or SMS Reminder will be sent. Also, caregivers will be requested to take pictures of their writings or if they have typed them, they will be requested to copy their texts and send them for researchers. The text of the instruction is as follows: 'You are expected to write at home or place of your choice, within 3 sessions of 20 minutes in 3 consecutive days about how you manage your time. The subject will be different in every 3 days: Day 1: You should write in detail about how you spent your time and what you have done during the last week. Day 2: You should write about the works that you have done over the last 24 hours. Day3: You should write in detail about what you intend to do in next 24 hours. When writing, you should try to write the work you have done or your planned actions accurately and avoid writing your feelings or comments on the work done or planned. For example, what activities did you do day by day or hour to hours. The time of writing is 20 minutes and do not worry about spelling, the structure of sentences and grammar, the only rule is to write freely when you start writing, and continue it until 20 minutes. After completing every 3 written sessions, take pictures of your writings or if you have typed them, copy the texts and send them to me. You do not need to write your name in the writing and your writings will be completely confidential, and your name and text will not be published somewhere.' Care burden score in Caregiver Burden Inventory by Novak & Guest. Timepoint: Before and one month after the intervention. Method of measurement: 24-item multi-dimensional questionnaire measuring caregiver burden with 5 subscales: Time Dependence; Developmental; Physical Burden; Social Burden; Emotional Burden. Scores for each item are evaluated using a 5-point Likert scale ranging from 0 (not at all disruptive) to 4 (very disruptive). The scores are variable from 0 to 96 and a higher score indicates a higher care burden. Anxiety score in Generalized Anxiety Disorder 7-item scale by Spitzer et al. Timepoint: Before and one month after the intervention. Method of measurement: Generalized Anxiety Disorder 7-item scale designed by Spitzer et al. It has 7 items, and an additional question that measures the interference of anxiety in individual, social, family and occupational functions. The subjects with choosing one of the options for no time, more than half of the days, and almost every day, answer questions, and options are graded with scores 1,0, 2 and 3, and thus the domain Scores are from 0 to 21. Score 0-4: Minimal Anxiety, Score 5-9: Mild Anxiety, Score 10-14: Moderate Anxiety, Score greater than 15: Severe Anxiety. The symptoms of depression (not diagnosis of depression) with depression score in Beck Depression Inventory (II). Timepoint: Before and one month after the intervention. Method of measurement: In this study, the symptoms of depression are identified (not diagnosis of depression), which is determined by the calculated score of the participants' response to the Beck Depression Inventory(II), which is a self-reporting tool for measuring the severity of depression. The overall score is in the range of 0 to 63, with a score of 0 to 13 no or low depression, 14 to 19 mild depression, 20 to 28 moderate depression and 29 to 63 severe depression. Tehran University of Medical Sciences Approved 2022-03-13 Institutional research ethics committee of Nursing, Midwifery & Rehabilitation school School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat st. Tohid sq., Tehran I.IRAN Tehran Tehran Iran (Islamic Republic of)