Mobile-Based Exercise in Postpartum Period

NCT06390540 | Not Yet Recruiting

• 1 other identifier: ANKARA-UNALS-001
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postpartum depression is a global mental health problem affecting 13 million women worldwide each year. It is defined as minor or major depression that occurs up to one year after birth and is estimated to affect 5 to 25% of mothers who have just given birth . Postpartum depression can cause negative consequences not only on the mother but also on the newborn and the whole family. The main goal in the postpartum period is to maintain the well-being of mother and baby. However, if a depression is experienced during this period, the main goal is to take action to reduce its severity. Exercise is a potentially promising method to prevent postpartum depression. However, more studies are needed to determine the effects of exercise on women who live in rural Türkiye and have limited access to health services. Therefore, this study aims to determine the effect of a mobile-based exercise program applied to women giving birth in rural areas on postpartum depression, mother-baby attachment and baby crying behavior.

Conditions

Postpartum Depression; Mother-Infant Interaction

Keywords

postpartum period; depression; mothers; exercise; babies and infants

Outcome Measures

Primary Outcomes (1)

• Chance from Baseline in Depression on the 30-point Edinburgh Postpartum Depression Scale at Week 8

  The Edinburgh Postpartum Depression Scale is a validated, self-reported instrument assessing average depression intensify postpartum period. Possible scores range from 0 (no depression) to 30 (depression). The scale consists of 10 questions in total. Each question provides a four-point Likert type measurement. The items in questions 3, 5, 6, 7, 8, 9 and 10 of the scale are scored as 3, 2, 1, 0 and gradually indicates decreasing intensity. The scoring of the items in questions 1, 2 and 4 is in the form of 0, 1, 2, 3, indicating increasing severity. By summing these items, the total score of the scale is obtained. The lowest total score that can be obtained on the scale is 0 and the highest is 30.

  Baseline and 8 week

Secondary Outcomes (1)

• Chance from Baseline in Mother-baby attachment on the 104-point Maternal Attachment Scale at Week 8

  Baseline and 8 week

Other Outcomes (1)

• Chance from Baseline in baby criying Baby Cry Diary at Week 8

  Baseline and 8 week

Study Arms (2)

Exercise Group

EXPERIMENTAL

In the study, women will perform breathing and relaxation exercises for 8 weeks. In the first phase of the intervention, women will be given home exercise program training. The training will be held face to face at the Family Health Center. The day and time will be determined according to the women's preference. Afterwards, women will be informed about the exercise program and the exercise program will be shared in writing. In the second phase of the intervention, a total of four exercise videos will be sent to women every two weeks on Sunday.Exercise videos will be sent to women through social networks such as WhatsApp, Instagram, Facebook and Twitter. Women's exercise routines will be recorded by researchers by calling the women and monitoring whether they do the exercises through self-report.

Other: Exercise

Control Group

NO INTERVENTION

No intervention will be made to women in the control group. When necessary, women's questions will be answered via phone. At the end of the study, breathing and relaxation exercise training will be given to the control group. Trainings will be held face to face at the Family Health Center. The training program will be planned taking into account the demands of women.

Interventions

Exercise OTHER

During the training, verbal information will be given about the importance of exercise, exercise barriers, and the potential benefits of exercise on the mother and baby in the postpartum period. In the training, the points that the mother should pay attention to before exercise will also be discussed. In the following process, videos containing deep breathing and relaxation exercises will be sent to women. The videos will be recorded by the researchers at Ankara University Physiotherapy application laboratory. Recording videos will be delivered to women through social networks. Women will be allowed to do these exercises for a total of 8 weeks.

Exercise Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Eligibility of participants is based on female gender representation.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Having had a singleton pregnancy,
• Not having a history of serious illness/chronic disease,
• Not being restricted from exercising by the physician,
• Having given birth at term (37-42 weeks of pregnancy),
• Being within the first 6 months after birth,
• Having a healthy baby,
• Knowing how to read and write Turkish and understanding it,
• Having the skills to use phones, tablets, computers and mobile applications,
• Not having any problems that would prevent communication,
• Agreeing to participate in the research. -

You may not qualify if:

• Having a history of multiple pregnancy,
• Being taking medication for the treatment of illness or chronic disease,
• Exercising regularly,
• Having a premature baby (\<37 weeks of gestation),
• Having a history of illness in the baby,
• Not having a phone, tablet or computer,
• Not agreeing to participate in the research. -

Sponsors & Collaborators

• Ankara University: lead
• republic of turkey ministry of health: collaborator

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Related Links

• NCSS. User's Guide I Quick Start, Proportions, and Diagnostic Tests PASS Power Analysis and Sample Size System
• T.C. Haymana Kaymakamlığı

MeSH Terms

Conditions

Depression, Postpartum; Depression; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

SERAP CANLI

CONTACT

+9005427897635; seunal@ankara.edu.tr

SERAP CANLI

CONTACT

05427897635; seunal@ankara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In the PASS 11 program, when the number of groups is calculated as 2, 5% margin of error and 90% power, it has been determined that at least 54 people should be included in the sample, with each group consisting of at least 27 people. Considering that the women taking part in the study may want to leave the study while it is ongoing and may encounter unexpected medical conditions and may be lost; It was decided to include a total of 80 women, 40 in the intervention group and 40 in the control group. In this single-blind randomized controlled study, the group in which women will be included will be determined and randomized via computer. "Random Allocation Software Program" will be used to randomize women to groups. The randomization process will be generated by the computer into random blocks of permuted length. Women will be assigned to one of the intervention and control groups by the researchers according to the order in the randomization list.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Public Health Nurse Lecturer

Model Details: This research will be conducted in accordance with the pre-test-post-test experimental research model in two groups in order to determine the effect of a mobile-based breathing and relaxation exercise program applied to postpartum women on postpartum depression, mother-infant attachment and baby crying behavior.

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 30, 2024
• Study Start: May 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: March 30, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share