StressNCT06300112
Prenatal Yoga on Stress, Quality of Sexual Life and Sleep Level
A study testing YOGA in people with Stress and Sexuality, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- What is being tested?
- YOGA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 30 Jun 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy week between 24 and 34,
- Able to read and write Turkish,
- No communication problems,
- Those who voluntarily agreed to participate in the research
Who cannot join
- Those who have risky pregnancies,
- Those with diagnosed psychiatric problems,
- Participating in a different training program (meditation, relaxation, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Amasya University
Amasya, 05100
Emine İbici Akça, Ph.D, 03582115005-4723, emine.akca@amasya.edu.tr
About this study
Official title: The Effect of Pregnancy Yoga on Perceived Stress, Quality of Sexual Life and Sleep Level
The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns.
Read the detailed description
Although pregnancy is a natural process, the change in physiological and psychosocial balance and the differentiation of roles in life require bio-psychosocial adaptation for the pregnant woman and her environment. In addition to strengthening the uterine and perineal muscles and supporting the spine, yoga is effective in dealing with common problems of pregnancy such as poor blood circulation, blood pressure fluctuations, excessive weight gain, fatigue, edema and urinary problems. The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns.
- Being tested
- YOGA
- Keywords
- Midwifery, Perceived Stress, Sexual Quality of Life, Sleep, Pregnancy
- Medical subject headings
- Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YOGABehavioural
Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Yoga Receives: Behavioral: YOGA |
| Control group | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress level
This will be measured using "Perceived Stress Scale". The minimum score that can be obtained from the scale is "0", the maximum score is "32", and as the scale score increases, perceived stress level also increase.
Measured: 6 weeks
Sexual Quality of Life
This will be measured using "Sexual Quality of Life Questionnaire-Female". The minimum score that can be obtained from the scale is "18", the maximum score is "108". The total score obtained from the scale must be converted to 100. As the scale score increases, perceived stress level also increase.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Model description
- A randomized-controlled trial with pretest-posttest control group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Akca, Amasya University
- Investigators
- Emine İbici Akça, Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300112
- Sponsor's protocol ID
- Amasya Univ_emine.akca
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2024
- Last updated
- 12 Mar 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pregnancy Yoga on Perceived Stress, Quality of Sexual Life and Sleep Level
- ClinicalTrials.gov ID
- NCT06300112
- Acronym / sponsor ID
- Amasya Univ_emine.akca
- Keywords
- Midwifery, Perceived Stress, Sexual Quality of Life, Sleep, Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 Mar 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 study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns.
Detailed description
Although pregnancy is a natural process, the change in physiological and psychosocial balance and the differentiation of roles in life require bio-psychosocial adaptation for the pregnant woman and her environment. In addition to strengthening the uterine and perineal muscles and supporting the spine, yoga is effective in dealing with common problems of pregnancy such as poor blood circulation, blood pressure fluctuations, excessive weight gain, fatigue, edema and urinary problems. The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized-controlled trial with pretest-posttest control group
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: YOGAYoga |
| Control group | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnancy week between 24 and 34,
- Able to read and write Turkish,
- No communication problems,
- Those who voluntarily agreed to participate in the research
Key exclusion criteria (3 listed)
- Those who have risky pregnancies,
- Those with diagnosed psychiatric problems,
- Participating in a different training program (meditation, relaxation, 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 |
|---|---|---|
| YOGAYoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. | Behavioural | Experimental group |
Primary outcome
Perceived stress level
Time frame: 6 weeks
This will be measured using "Perceived Stress Scale". The minimum score that can be obtained from the scale is "0", the maximum score is "32", and as the scale score increases, perceived stress level also increase.
Sexual Quality of Life
Time frame: 6 weeks
This will be measured using "Sexual Quality of Life Questionnaire-Female". The minimum score that can be obtained from the scale is "18", the maximum score is "108". The total score obtained from the scale must be converted to 100. As the scale score increases, perceived stress level also increase.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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.
Emine İbici Akça principal investigator
Amasya University
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 Stress and Sexuality, run by Amasya 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 3 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 12 Mar 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. 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 Emine İbici Akça, Ph.D (03582115005-4723, emine.akca@amasya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress level (time frame: 6 weeks). The study lists 2 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 12 Mar 2024.