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IRCT20230629058620N1 IRCT 2023-07-09 Arak University of Medical Sciences Comparison of the effect of mindfulness- based counseling and acupressure on pregnant women's sleep quality Comparison of the effect of mindfulness- based counseling and acupressure on pregnant women's sleep quality 2023-09-23 anticipated 90 Complete https://irct.ir/trial/71018 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: To randomize participants into three groups of 30 people (two intervention groups and one control group), we use the block permutation randomization method in order to balance the number of samples allocated in each group, and blocks of 6, with We arrange three letters ABC with equal letters as follows: block 1: BCACAB and BBCACA block 2: and block 3: BCAABC ..... and so on for different sequences. We select these blocks from the above permutations using random allocation software, which is capable of generating a random sequence by block method, and finally divide them into three groups: A (mindfulness intervention), B (acupressure intervention) and C. (control group) are divided. N/A Sleep quality in pregnancy. Intervention 1: Intervention group: The intervention of the first group of counseling on mindfulness: which includes 8 weekly 90-minute training sessions in groups (groups of 15 people) that will be delivered to the supervisors and counselors. The researcher will train the mind with the help of teaching and response techniques, role playing, doing class and homework assignments. The sessions will be based on basic training and exercises such as meditation, body scan, mindfulness meditation, and three-minute breathing exercises, etc., which will focus on paying attention to the events taking place in the present and understanding and accepting these events without any judgment and It will teach judgment to pregnant mothers and finally mothers will learn that instead of denying or avoiding negative thoughts and unpleasant events, they accept them and are aware of their reaction to them and show an appropriate reaction in dealing with them. give In the first session, a homework sheet will be provided to mothers, which they must complete weekly. The sessions will be held in the training hall of Kashan health centers, and the researcher who has already completed the specialized counseling course based on mindfulness and will conduct the sessions under the supervision of the clinical psychologist who is a member of the research. In order to evaluate the effectiveness of mindfulness counseling, the participants will be asked to complete the Pittsburgh Sleep Quality Questionnaire after the eighth session and also 1 month after the completion of the mindfulness training sessions. Intervention 2: The second group is the acupressure intervention, which is performed in the form of individual and face-to-face acupressure training on the HT7 point (Shen Man point) on the pea-shaped bone of the wrists (in the transverse crease of the wrists in the angle between the pea-shaped bone and the ulnar bone). It will include the pressure applied by the thumb on the mentioned point for 5 minutes (10 seconds of pressure and 2 seconds of rest). After 5 minutes, the same thing is done on the desired point on the other hand. In total, each intervention takes 10 minutes. The pressure is applied for 5 minutes in such a way that the pregnant mother feels warmth, heaviness, swelling or numbness at that point. The process of intervention is 1 time at night, before sleep and for 4 weeks. Before starting the research, the researcher should be trained in acupressure and acquire the necessary skills to find the desired point with 100% accuracy and correctly identify the desired point on 10 participants. The training of the participants in the study regarding the method of finding the desired point and the amount of applying pressure on it will be done verbally and in writing by presenting a pamphlet by the researcher. The participants will be invited to perform acupressure on the mentioned points once in the presence of the researcher so that necessary guidance can be provided if needed. Then the participants in the intervention will complete the Pittsburgh Sleep Quality Questionnaire immediately after the 4-week intervention and 1 month after the end of the intervention. The intervention of this group will be done one month after the intervention of the first group so that the time to complete the Pittsburgh sleep quality questionnaire is the same in all three groups. Intervention 3: Control group: receiving routine care and training according to the gestational age and completing the Pittsburgh sleep quality questionnaire at the time of entering the study, 8 weeks later and 12 weeks later. Yes - There is a plan to make this available What will be shared: Publication in the article When: Six months after the end of the study To whom: Health care centers, managers, training centers Conditions: Educational, therapeutic and planning use Where to obtain: Public respondent How to obtain: First, it should be requested and approved by the Research Vice-Chancellor of Arak University of Medical Sciences. Then correspond with the public respondent Comments:
public Azam Toranjinejad
No.17,Tovhid 18 Alley , 22 Bahman Street
Kashan Iran (Islamic Republic of) 8715178145 +98 31 5545 5220 a.toranjinejad@arakmu.ac.ir Arak University of Medical Sciences scientific Fereshteh Farzanazar
Basij Square (Sardasht), Arak University of Medical Sciences, Faculty of Medicine
Arak Iran (Islamic Republic of) 3848176341 +98 86 3383 8237 farzanazar@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Women with low-risk pregnancies Age 18-35 years Gestational age 16-24 weeks Literacy for reading and writing Willingness to participate in the study Having an unfavorable sleep quality (getting a score of 5 or more after completing the questionnaire) 18 years 35 years Female Smoker or drug abuse Taking anti-depressants and anxiety medications Medical or psychological illness (such as diabetes, chronic hypertension, mental disease, etc.) abnormal findings in the hands G47.8 Other sleep disorders Other Other Other Intervention group: The intervention of the first group of counseling on mindfulness: which includes 8 weekly 90-minute training sessions in groups (groups of 15 people) that will be delivered to the supervisors and counselors. The researcher will train the mind with the help of teaching and response techniques, role playing, doing class and homework assignments. The sessions will be based on basic training and exercises such as meditation, body scan, mindfulness meditation, and three-minute breathing exercises, etc., which will focus on paying attention to the events taking place in the present and understanding and accepting these events without any judgment and It will teach judgment to pregnant mothers and finally mothers will learn that instead of denying or avoiding negative thoughts and unpleasant events, they accept them and are aware of their reaction to them and show an appropriate reaction in dealing with them. give In the first session, a homework sheet will be provided to mothers, which they must complete weekly. The sessions will be held in the training hall of Kashan health centers, and the researcher who has already completed the specialized counseling course based on mindfulness and will conduct the sessions under the supervision of the clinical psychologist who is a member of the research. In order to evaluate the effectiveness of mindfulness counseling, the participants will be asked to complete the Pittsburgh Sleep Quality Questionnaire after the eighth session and also 1 month after the completion of the mindfulness training sessions. The second group is the acupressure intervention, which is performed in the form of individual and face-to-face acupressure training on the HT7 point (Shen Man point) on the pea-shaped bone of the wrists (in the transverse crease of the wrists in the angle between the pea-shaped bone and the ulnar bone). It will include the pressure applied by the thumb on the mentioned point for 5 minutes (10 seconds of pressure and 2 seconds of rest). After 5 minutes, the same thing is done on the desired point on the other hand. In total, each intervention takes 10 minutes. The pressure is applied for 5 minutes in such a way that the pregnant mother feels warmth, heaviness, swelling or numbness at that point. The process of intervention is 1 time at night, before sleep and for 4 weeks. Before starting the research, the researcher should be trained in acupressure and acquire the necessary skills to find the desired point with 100% accuracy and correctly identify the desired point on 10 participants. The training of the participants in the study regarding the method of finding the desired point and the amount of applying pressure on it will be done verbally and in writing by presenting a pamphlet by the researcher. The participants will be invited to perform acupressure on the mentioned points once in the presence of the researcher so that necessary guidance can be provided if needed. Then the participants in the intervention will complete the Pittsburgh Sleep Quality Questionnaire immediately after the 4-week intervention and 1 month after the end of the intervention. The intervention of this group will be done one month after the intervention of the first group so that the time to complete the Pittsburgh sleep quality questionnaire is the same in all three groups. Control group: receiving routine care and training according to the gestational age and completing the Pittsburgh sleep quality questionnaire at the time of entering the study, 8 weeks later and 12 weeks later. Sleep quality score. Timepoint: Before the interventions, immediately and one month after the interventions. Method of measurement: Pittsburgh Standardized Sleep Quality Questionnaire. Arak University of Medical Sciences Approved 2023-06-06 Ethics Committee of Arak University of Medical Sciences Basij Square (Sardasht), Arak University of Medical Sciences, University Complex of the Great Prophet (PBUH), Deputy for Research and Technology Arak Markazi Iran (Islamic Republic of)