Mother-Child RelationsNCT06359184
Yoga, Mother's Stress and Baby
A study testing yoga in people with Mother-Child Relations, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effects of yoga on the stress of mothers with babies with sleep and feeding problems, the mother-infant relationship, and the sleep and nutrition of the mother and the baby. 55 mothers with babies with sleep and feeding problems were included in the study. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mother-Child Relations
- What is being tested?
- yoga
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents living together The child must have at least one of the 3 problems listed below on the Infant/Child Sleep Problem Brief Diagnostic Form.
- Waking up more than three times a night
- Waking up at night and being sleepless for more than 1 hour
- Total sleep time is less than 9 hours Having a score above 25 on the Infancy Adaptive Eating Behavior Scale
Who cannot join
- The child has any developmental, neurological, orthopedic and/or psychiatric diagnosis Presence of a condition that prevents the mother from exercising (neurological, cardiovascular, orthopedic, etc.)
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effect of Yoga on Maternal Stress and Sleep Quality of Mother and Baby, Mother's Feeding Attitude and Baby's Feeding Behavior: Randomized Controlled Study.
The aim of this study is to examine the effects of yoga on the stress of mothers with babies with sleep and feeding problems, the mother-infant relationship, and the sleep and nutrition of the mother and the baby. 55 mothers with babies with sleep and feeding problems were included in the study. Mothers were randomly divided into two groups: yoga (n=29) and control group (n=26). Yoga training was applied to 29 mothers in the study group via video conferencing, 2 days a week, 1 hour a day for 8 weeks, while the mothers in the control group were given second evaluations 8 weeks after the first evaluation, without any intervention. Mothers were evaluated with the Perceived Stress Scale (PSS) for stress levels, with Parent-Child Containing Function Scale for the mother-infant relationship, with the Infancy and Early Childhood Feeding Process Mother'sAttitudes Scale for their attitudes towards the feeding process of their babies, and with Attitude Scale for Healthy Nutrition (ASHN) for their own nutrition attitudes, with Pittsburg Sleep Quality (PSQI) for sleep quality and babies with Infancy Period Adaptive Eating Behavior Scale for feeding problems, with Brief Infant/Child Sleep Questionnaire (BISQ) for sleep problems.
- Conditions
- Mother-Child Relations
- Being tested
- yoga, control
- Keywords
- yoga, mothers, baby, stress, sleep, nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaOther
1 hour yoga practice 2 days a week for 8 weeks
controlOther
no intervention for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| yoga | Experimental | Yoga will be practiced 1 hour a day, 2 days a week for 8 weeks, for a total of 16 hours. Receives: Other: yoga |
| control | Placebo comparator | No intervention is applied for 8 weeks. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)
Evaluated for mother's stress level. It evaluates the participants on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4).
Measured: At the beginning and end of 8 weeks
Infancy and Early Childhood Feeding Process Mother's Attitudes Scale
Evaluated Mother's attitudes towards the feeding process of their babies
Measured: At the beginning and end of 8 weeks
Pittsburg Sleep Quality (PSQI)
Evaluated mother's sleep quality
Measured: At the beginning and end of 8 weeks
Period Adaptive Eating Behavior Scale
Evaluated babies feeding problems
Measured: At the beginning and end of 8 weeks
Brief Infant/Child Sleep Questionnaire (BISQ)
Evaluated babies sleep problems. If at least one of the following three conditions occurs, it is determined that the baby/child has a sleep problem; 1) The baby/child wakes up more than three times a night, 2) The baby/child wakes up at night and remains sleepless for more than an hour, or, 3) The baby/child's total sleep time is less than 9 hours.
Measured: At the beginning and end of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Nov 2023
- Primary completion1 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mother-Child RelationsStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Nur Ozan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359184
- Sponsor's protocol ID
- GO21/1011
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Yoga on Maternal Stress and Sleep Quality of Mother and Baby, Mother's Feeding Attitude and Baby's Feeding Behavior: Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06359184
- Acronym / sponsor ID
- GO21/1011
- Conditions
- Mother-Child Relations
- Keywords
- yoga, mothers, baby, stress, sleep, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 11 Apr 2024 (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 examine the effects of yoga on the stress of mothers with babies with sleep and feeding problems, the mother-infant relationship, and the sleep and nutrition of the mother and the baby. 55 mothers with babies with sleep and feeding problems were included in the study. Mothers were randomly divided into two groups: yoga (n=29) and control group (n=26). Yoga training was applied to 29 mothers in the study group via video conferencing, 2 days a week, 1 hour a day for 8 weeks, while the mothers in the control group were given second evaluations 8 weeks after the first evaluation, without any intervention. Mothers were evaluated with the Perceived Stress Scale (PSS) for stress levels, with Parent-Child Containing Function Scale for the mother-infant relationship, with the Infancy and Early Childhood Feeding Process Mother'sAttitudes Scale for their attitudes towards the feeding process of their babies, and with Attitude Scale for Healthy Nutrition (ASHN) for their own nutrition attitudes, with Pittsburg Sleep Quality (PSQI) for sleep quality and babies with Infancy Period Adaptive Eating Behavior Scale for feeding problems, with Brief Infant/Child Sleep Questionnaire (BISQ) for sleep problems.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| yoga | Experimental | Other: yogaYoga will be practiced 1 hour a day, 2 days a week for 8 weeks, for a total of 16 hours. |
| control | Placebo comparator | Other: controlNo intervention is applied for 8 weeks. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Parents living together The child must have at least one of the 3 problems listed below on the Infant/Child Sleep Problem Brief Diagnostic Form.
- Waking up more than three times a night
- Waking up at night and being sleepless for more than 1 hour
- Total sleep time is less than 9 hours Having a score above 25 on the Infancy Adaptive Eating Behavior Scale
Key exclusion criteria (2 listed)
- The child has any developmental, neurological, orthopedic and/or psychiatric diagnosis Presence of a condition that prevents the mother from exercising (neurological, cardiovascular, orthopedic, etc.)
- -
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 |
|---|---|---|
| yoga1 hour yoga practice 2 days a week for 8 weeks | Other | yoga |
| controlno intervention for 8 weeks | Other | control |
Primary outcome
Perceived Stress Scale (PSS)
Time frame: At the beginning and end of 8 weeks
Evaluated for mother's stress level. It evaluates the participants on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4).
Infancy and Early Childhood Feeding Process Mother's Attitudes Scale
Time frame: At the beginning and end of 8 weeks
Evaluated Mother's attitudes towards the feeding process of their babies
Pittsburg Sleep Quality (PSQI)
Time frame: At the beginning and end of 8 weeks
Evaluated mother's sleep quality
Period Adaptive Eating Behavior Scale
Time frame: At the beginning and end of 8 weeks
Evaluated babies feeding problems
Brief Infant/Child Sleep Questionnaire (BISQ)
Time frame: At the beginning and end of 8 weeks
Evaluated babies sleep problems. If at least one of the following three conditions occurs, it is determined that the baby/child has a sleep problem; 1) The baby/child wakes up more than three times a night, 2) The baby/child wakes up at night and remains sleepless for more than an hour, or, 3) The baby/child's total sleep time is less than 9 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga in people with Mother-Child Relations, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS) (time frame: At the beginning and end of 8 weeks). The study lists 5 primary outcomes in all. 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 11 Apr 2024.