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IRCT20190611043866N1 IRCT 2020-03-31 Birjand University of Medical Sciences The effect of mindfulness-based intervention on caregiver burden, perceived stress, and quality of life in family caregivers of patients with cancer The effect of mindfulness-based intervention on caregiver burden, perceived stress, and quality of life in family caregivers of patients with cancer 2019-03-03 anticipated 60 Complete https://irct.ir/trial/40158 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The study included two intervention and control groups (30 in each group). The intervention group received eight sessions of mindfulness program training for two hours and then completed the intervention Followed for two months. But during this time the control group does not receive any intervention, Randomization description: Referring to Iran-Mehr Hospital 60 family caregivers of patients with cancer are included in the study through available sampling. Then Samples were randomly divided into intervention and control groups, Respectively and one by one (each group 30). N/A cancer. Intervention 1: session 1, goals and techniques included building a rapport with the client, obtaining information from the client, providing psycho-education on mindfulness, CBT, depression, and anxiety, identifying automatic thoughts and leading the client through a guided mindfulness meditation. session 2, goals and techniques included helping the client recognize that most of her thoughts are not facts, teaching the client to use the thought record, educating client about cognitive distortion. session 3, goals and techniques included educating diaphragmatic breathing and sleep hygiene; next, teaching the client a brief body scan exercise to reduce muscle tension. session 4, goals and techniques included introducing mindful daily activity, teaching mindful eating and mindful labelling on thoughts, feelings and behaviours. session 5, goals and techniques included introducing to enhancing recognition of personal consequences of chronic worry, having the client perform a cost-benefit analysis of her chronic worry, scheduling worry time and mindful worry-free zones. session 6, goals and techniques included generating a hierarchy of worries, imaginary exposure with acceptance, incorporating in vivo exposure through increased participation in planned events. session 7, goals and techniques included helping the client learn to identify and respond to early signs of relapse, collaborating with the client to generate responses to her early warning signs, helping the client practice developing a worry action plan. session 8, goals and techniques included reviewing the insights and techniques found most useful by the client, identifying obstacles to practice mindfulness, providing a checklist of the techniques included in the program. Intervention 2: Control group: They do not receive any intervention. 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 No decision has been made for it
public Zeinab Mehrizi
No. 118, Taleghani Alley 17, Taleghani St, Esfarayen, North Khorasan Province.
Esfarayen Iran (Islamic Republic of) 9661884915 +98 58 3723 4082 zeinab.mehrizi@gmail.com Birjand University of Medical Sciences scientific Zeinab Mehrizi
No. 118, Taleghani Alley 17, Taleghani St, Esfarayen, North Khorasan Province.
Esfarayen Iran (Islamic Republic of) 9661884915 +98 58 3723 4082 zeinab.mehrizi@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria for Cancer Patients: Being at least 18 years of age or older having a cancer diagnosis approved by a specialist physician undergoing cancer treatment if the cancer treatment course is completed, more than four weeks after Do not end the treatment period having a family caregiver who will take care of him at home Inclusion criteria for caregivers: Women and men aged 18-75 years able to read, write and speak Persian play a key role in patient care have a family relationship with the patient (spouse, child, parent or mother, sister or Brother, grandson, other relatives) Willingness to participate in the program lack of specific illness or unstable situation unable to care for a cancer patient No cancer diagnosed in the past 4 years No regular treatment by a psychologist or psychiatrist Lack of self-reported diagnosis of mental disorders and cognitive impairment Non-admission to psychiatric ward with diagnosis of psychiatric disorders in the past two years No history of suicide No treatment with anti psychotic and anti-convulsive drugs No substance abuse or dependence in the past year No recent recovery from substance abuse Lack of previous or current participation in mindfulness programs and other psycho-social programs Lack of do yoga and meditation exercises in the past year 18 years 75 years Both Having more than two sessions absent on schedule Unwillingness or inability to continue participating in the study Death of cancer patient during research The occurrence of any physical or mental disorders that prevent the caregiving by the caregiver Behavior N/A session 1, goals and techniques included building a rapport with the client, obtaining information from the client, providing psycho-education on mindfulness, CBT, depression, and anxiety, identifying automatic thoughts and leading the client through a guided mindfulness meditation. session 2, goals and techniques included helping the client recognize that most of her thoughts are not facts, teaching the client to use the thought record, educating client about cognitive distortion. session 3, goals and techniques included educating diaphragmatic breathing and sleep hygiene; next, teaching the client a brief body scan exercise to reduce muscle tension. session 4, goals and techniques included introducing mindful daily activity, teaching mindful eating and mindful labelling on thoughts, feelings and behaviours. session 5, goals and techniques included introducing to enhancing recognition of personal consequences of chronic worry, having the client perform a cost-benefit analysis of her chronic worry, scheduling worry time and mindful worry-free zones. session 6, goals and techniques included generating a hierarchy of worries, imaginary exposure with acceptance, incorporating in vivo exposure through increased participation in planned events. session 7, goals and techniques included helping the client learn to identify and respond to early signs of relapse, collaborating with the client to generate responses to her early warning signs, helping the client practice developing a worry action plan. session 8, goals and techniques included reviewing the insights and techniques found most useful by the client, identifying obstacles to practice mindfulness, providing a checklist of the techniques included in the program. Control group: They do not receive any intervention. Weitzner's Quality of Life Questionnaire score. Timepoint: Before and after the intervention and two months after the intervention. Method of measurement: weitzner's Quality of life questionnaire for caregivers of cancer patients. Cohen's perceived stress Questionnaire score. Timepoint: Before and after the intervention and two months after the intervention. Method of measurement: Cohen's perceived stress Questionnaire. Zarit's caregiver burden Questionnaire score. Timepoint: Before and after the intervention and two months after the intervention. Method of measurement: Zarit's caregiver burden Questionnaire. Birjand University of Medical Sciences Approved 2019-01-07 Ethics Committee of Birjand University of Medical Sciences No. 118, Taleghani Alley 17, Taleghani Ave, Esfarain, North Khorasan Province Birjand South Khorasan Iran (Islamic Republic of)