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IRCT20120718010324N63 IRCT 2021-02-13 Tabriz University of Medical Sciences The effect of cognitive-behavioral counseling on sleep quality of pregnant women The effect of cognitive-behavioral counseling with/without Neroli essence on sleep quality of pregnant women: a randomised controlled trial 2021-01-08 anticipated 75 Complete https://irct.ir/trial/52146 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be assigned to the three groups including: Intervention group 1: Recipient of cognitive-behavioral counseling and placebo of Neroli essence, Second intervention group: Recipient of cognitive-behavioral counseling with aromatherapy with Neroli essence and control group by the block randomization method with block sizes of 6 and 9 and with a 1: 1: 1 allocation ratio. In order to hide the allocation (Allocation Concealment), the type of intervention is written on paper and sealed in opaque envelopes. The envelopes will be opened in order of the participants entering the study and the type of group will be determined. Random allocation and preparation of envelopes will be done by a person not involved in sampling and data collection. N/A Sleep quality. Intervention 1: The first intervention group will receive cognitive-behavioral counseling and placebo of Neroli essence. Counseling will be provided in 8 group sessions in native language. The average duration of counseling sessions will be 60 to 90 minutes. Also, 2 drops of placebo of Neroli essence will be inhaled by the participants for 15-20 minutes before going to bed. The protocol of cognitive-behavioral counseling approach will be as follows: Session 1: Explaining the goals of training and acquaintance with members, conducting a pre-test, teaching how to monitor the baseline of sleep with a sleep report table, reminding the importance of treatment tasks, a complete assessment of the nature of insomnia; Session 2: Presenting the principles and logic of treatment, teaching the mechanism of sleep and its stages, sleep-wake cycles, predisposing, maintenance and persistence factors of insomnia, relaxation education; Session 3: Reviewing the previous treatment session, assessing the findings of the sleep report form, sleep hygiene training, and reviewing the relaxation and new sleep schedule; Session 4: Restricting sleep, preventing daily naps, evaluating thoughts and teaching how to record thoughts related to insomnia, reviewing and assessing the assignments of previous sessions (sleep report form and homework assignment); Session 5: Summarizing thoughts, problem solving skills, reviewing the sleep report form and homework assignments and troubleshooting; Session 6: Introduce the cycle of thinking, feeling and behavior, reviewing the relaxation and teaching not to try in vain to fall asleep and apply all the instructions of the previous sessions and reviewing the homework of the previous sessions (sleep report form and homework assignments); Session 7: Training the thought blocking, mental imaging, troubleshooting about cognitive-behavioral therapy plan, reviewing the patient's homework; Session 8: Reviewing and troubleshooting the cognitive-behavioral treatment plan, noting the progress of treatment according to the sleep calendar. Intervention 2: The second ntervention group will receive cognitive-behavioral counseling and Neroli essence. Counseling will be provided in 8 group sessions in native language. The average duration of counseling sessions will be 60 to 90 minutes. Also, 2 drops of Neroli essence will be inhaled by the participants for 15-20 minutes before going to bed. The protocol of cognitive-behavioral counseling approach will be as follows: Session 1: Explaining the goals of training and acquaintance with members, conducting a pre-test, teaching how to monitor the baseline of sleep with a sleep report table, reminding the importance of treatment tasks, a complete assessment of the nature of insomnia; Session 2: Presenting the principles and logic of treatment, teaching the mechanism of sleep and its stages, sleep-wake cycles, predisposing, maintenance and persistence factors of insomnia, relaxation education; Session 3: Reviewing the previous treatment session, assessing the findings of the sleep report form, sleep hygiene training, and reviewing the relaxation and new sleep schedule; Session 4: Restricting sleep, preventing daily naps, evaluating thoughts and teaching how to record thoughts related to insomnia, reviewing and assessing the assignments of previous sessions (sleep report form and homework assignment); Session 5: Summarizing thoughts, problem solving skills, reviewing the sleep report form and homework assignments and troubleshooting; Session 6: Introduce the cycle of thinking, feeling and behavior, reviewing the relaxation and teaching not to try in vain to fall asleep and apply all the instructions of the previous sessions and reviewing the homework of the previous sessions (sleep report form and homework assignments); Session 7: Training the thought blocking, mental imaging, troubleshooting about cognitive-behavioral therapy plan, reviewing the patient's homework; Session 8: Reviewing and troubleshooting the cognitive-behavioral treatment plan, noting the progress of treatment according to the sleep calendar. Intervention 3: The control group will receive pregnancy routine care. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participant data is confidential
public Narges Rahmani
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5358153561 +98 41 3341 4567 nargesrahmani313@gmail.com Tabriz University of Medical Sciences scientific Dr. Mojgan Mirghafourvand
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947979 +98 41 3177 2048 mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Pregnant women with a gestational age of 20 to 24 weeks Women with poor sleep quality based on the Pittsburgh Sleep Quality Questionnaire (score above 5) Has a minimum secondary education degree Living in Tabriz Pregnant women with a file in the health center (Sib system) No olfactory problems and sensitivity to herbal medicines according to the patient's report Achieving a depression score of 12 or lower based on the Edinburgh Depression Inventory no limit no limit Female Pregnant mothers with mental illnesses and a history of hospitalization in a psychiatric hospital and the use of any psychological medication based on the individual expression Mothers addicted to drugs and cigarettes according to the individual expression Mothers with high-risk pregnancies, including diabetes, high blood pressure, chronic diseases affecting pregnancy, such as cardiovascular, lung and .... Mothers with obstetrics problems including bleeding, history of preterm delivery and ... G47.9 Sleep disorder, unspecified Behavior Behavior Other The first intervention group will receive cognitive-behavioral counseling and placebo of Neroli essence. Counseling will be provided in 8 group sessions in native language. The average duration of counseling sessions will be 60 to 90 minutes. Also, 2 drops of placebo of Neroli essence will be inhaled by the participants for 15-20 minutes before going to bed. The protocol of cognitive-behavioral counseling approach will be as follows: Session 1: Explaining the goals of training and acquaintance with members, conducting a pre-test, teaching how to monitor the baseline of sleep with a sleep report table, reminding the importance of treatment tasks, a complete assessment of the nature of insomnia; Session 2: Presenting the principles and logic of treatment, teaching the mechanism of sleep and its stages, sleep-wake cycles, predisposing, maintenance and persistence factors of insomnia, relaxation education; Session 3: Reviewing the previous treatment session, assessing the findings of the sleep report form, sleep hygiene training, and reviewing the relaxation and new sleep schedule; Session 4: Restricting sleep, preventing daily naps, evaluating thoughts and teaching how to record thoughts related to insomnia, reviewing and assessing the assignments of previous sessions (sleep report form and homework assignment); Session 5: Summarizing thoughts, problem solving skills, reviewing the sleep report form and homework assignments and troubleshooting; Session 6: Introduce the cycle of thinking, feeling and behavior, reviewing the relaxation and teaching not to try in vain to fall asleep and apply all the instructions of the previous sessions and reviewing the homework of the previous sessions (sleep report form and homework assignments); Session 7: Training the thought blocking, mental imaging, troubleshooting about cognitive-behavioral therapy plan, reviewing the patient's homework; Session 8: Reviewing and troubleshooting the cognitive-behavioral treatment plan, noting the progress of treatment according to the sleep calendar. The second ntervention group will receive cognitive-behavioral counseling and Neroli essence. Counseling will be provided in 8 group sessions in native language. The average duration of counseling sessions will be 60 to 90 minutes. Also, 2 drops of Neroli essence will be inhaled by the participants for 15-20 minutes before going to bed. The protocol of cognitive-behavioral counseling approach will be as follows: Session 1: Explaining the goals of training and acquaintance with members, conducting a pre-test, teaching how to monitor the baseline of sleep with a sleep report table, reminding the importance of treatment tasks, a complete assessment of the nature of insomnia; Session 2: Presenting the principles and logic of treatment, teaching the mechanism of sleep and its stages, sleep-wake cycles, predisposing, maintenance and persistence factors of insomnia, relaxation education; Session 3: Reviewing the previous treatment session, assessing the findings of the sleep report form, sleep hygiene training, and reviewing the relaxation and new sleep schedule; Session 4: Restricting sleep, preventing daily naps, evaluating thoughts and teaching how to record thoughts related to insomnia, reviewing and assessing the assignments of previous sessions (sleep report form and homework assignment); Session 5: Summarizing thoughts, problem solving skills, reviewing the sleep report form and homework assignments and troubleshooting; Session 6: Introduce the cycle of thinking, feeling and behavior, reviewing the relaxation and teaching not to try in vain to fall asleep and apply all the instructions of the previous sessions and reviewing the homework of the previous sessions (sleep report form and homework assignments); Session 7: Training the thought blocking, mental imaging, troubleshooting about cognitive-behavioral therapy plan, reviewing the patient's homework; Session 8: Reviewing and troubleshooting the cognitive-behavioral treatment plan, noting the progress of treatment according to the sleep calendar. The control group will receive pregnancy routine care. Sleep quality. Timepoint: Immediately and four weeks after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Anxiety. Timepoint: Immediately and four weeks after the intervention. Method of measurement: Pregnancy Anxiety Questionnaire. Quality of life. Timepoint: Immediately and four weeks after the intervention. Method of measurement: Quality of Life Questionnaire. Tabriz University of Medical Sciences Approved 2020-12-29 Ethics committee of Tabriz University of Medical Sciences Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)