Postpartum WomenNCT05721625
Comparison of the Effects of Aerobic Exercise and Connective Tissue Massage in Postpartum Women
A study testing Aerobic exercise and Connective tissue massage in people with Postpartum Women, run by Ankara Yildirim Beyazıt University.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Women
- What is being tested?
- Aerobic exercise and Connective tissue massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postpartum 6th week-1 year
- Between the ages of 18-45
- Being literate
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Postpartum Women
- Being tested
- Aerobic exercise, Connective tissue massage
- Keywords
- sleep, depression, massage, exercise
- Medical subject headings
- Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
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 massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 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 Receives: Other: Aerobic exercise |
| Massage group | Active comparator | 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. Receives: Other: Connective tissue massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline at 8 weeks
Secondary outcomes (2)
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.
Measured: change from baseline at 8 weeks
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.
Measured: change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum WomenStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Study director, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721625
- Sponsor's protocol ID
- 2023/02/01
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Aerobic Exercise and Connective Tissue Massage in Postpartum Women
- ClinicalTrials.gov ID
- NCT05721625
- Acronym / sponsor ID
- 2023/02/01
- Conditions
- Postpartum Women
- Keywords
- sleep, depression, massage, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Aerobic exerciseThe aerobic exercise program will be applied at moderate intensity 3 days a week for 8 weeks. Walking will be recommended as an aerobic exercise |
| Massage group | Active comparator | Other: Connective tissue massageConnective 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Postpartum 6th week-1 year
- Between the ages of 18-45
- Being literate
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseThe 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 | Exercise group |
| Connective tissue massageConnective 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. | Other | Massage group |
Primary outcome
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.
2 secondary outcomes
Mother to Infant Bonding Scale
Time frame: change from baseline at 8 weeks
Edinburgh Postpartum Depression Scale
Time frame: change from baseline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyda Toprak Celenay study director
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Connective tissue massage in people with Postpartum Women, run by Ankara Yildirim Beyazıt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Sleep Quality Scale (time frame: change from baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.