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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05721625
Other study ID # 2023/02/01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 15, 2023
Est. completion date February 15, 2024

Study information

Verified date February 2023
Source Ankara Yildirim Beyazit University
Contact Seyda Toprak Celenay
Phone +90312 906 1000
Email sydtoprak@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the effects of aerobic exercise and connective tissue massage on sleep, mother-infant attachment and psychological state in postpartum women.


Description:

Postpartum period can affect the mental and physical health of women. Women may experience sleep problems and psychological problems due to hormonal changes and newborn care responsibilities. As a result, mother-infant attachment may also be affected. Physical activity and exercise should be encouraged in the postpartum period. It is known that aerobic exercises have positive effects on sleep and psychological problems. With the effects of connective tissue massage on the autonomic and circulatory system in the body, positive effects on sleep and psychological state can be achieved, but there are insufficient studies on this subject. In addition, no study has been found to the best of our knowledge comparing the effects of aerobic exercise and connective tissue massage in postpartum women.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date February 15, 2024
Est. primary completion date April 15, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Postpartum 6th week-1 year - Between the ages of 18-45 - Being literate Exclusion Criteria: - Those with orthopedic, neurological, rheumatological, mental or any systemic chronic diseases - Those with cardiac problems that may interfere with exercise - Those with suspected pregnancy - Those with malignancy - Those who have infection - Those who do not regularly participate in the treatment program

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic exercise
The aerobic exercise program will be applied at moderate intensity 3 days a week for 8 weeks. Walking will be recommended as an aerobic exercise
Connective tissue massage
Connective tissue massage will be applied by the physiotherapist 3 days a week for 8 weeks. While the patients are in the sitting position, this massage will be applied on whole back.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Outcome

Type Measure Description Time frame Safety issue
Primary Postpartum Sleep Quality Scale In order to measure Postpartum Sleep Quality, Postpartum Sleep Quality Scale will be used. The scale includes 14 items. The lowest score that can be obtained from the scale is 0, and the highest score is 56. An increase in the score indicates a decrease in sleep quality. change from baseline at 8 weeks
Secondary Mother to Infant Bonding Scale The Mother to Infant Bonding Scale, which was developed to be applied to the mother from the first day immediately after birth and allows the mother to express her feelings towards her baby in one word, will be used. This scale consists of 8 items. The lowest score that can be obtained from the scale is 0 and the highest score is 24. As the score obtained from the scale increases, the level of mother-infant attachment decreases. change from baseline at 8 weeks
Secondary Edinburgh Postpartum Depression Scale The Edinburgh Postpartum Depression Scale, which was prepared for screening purposes to determine the risk of depression in postpartum women, is not intended to diagnose depression. This scale consists of 10 items. The lowest score that can be obtained from the scale is 0 and the highest score is 30. The cut-off point of the scale was calculated as 13, and women with a scale score of 13 or more were considered as the risk group. change from baseline at 8 weeks
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