Comparison of the Effects of Aerobic Exercise and Connective Tissue Massage in Postpartum Women

February 1, 2023 updated by: seyda toprak celenay, Ankara Yildirim Beyazıt University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exercise group
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
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
ACTIVE_COMPARATOR: Massage group
Connective tissue massage will be applied by the physiotherapist 3 days a week for 8 weeks. While postpartum women are in the sitting position, this massage will be applied on whole back.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum Sleep Quality Scale
Time Frame: change from baseline at 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mother to Infant Bonding Scale
Time Frame: change from baseline at 8 weeks
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
Edinburgh Postpartum Depression Scale
Time Frame: change from baseline at 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 15, 2023

Primary Completion (ANTICIPATED)

April 15, 2023

Study Completion (ANTICIPATED)

February 15, 2024

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 10, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023/02/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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