Pregnancy RelatedNCT04764838
The Effect of Yoga on Sexual Function in Primiparous Pregnants
A study testing Yoga in people with Pregnancy Related and Sexual Dysfunction, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned as a single blind randomized controlled type in order to examine the effect of yoga on sexual function in primipara pregnant women.150 pregnant women will be randomized.The data will be interviewed online with pregnant women and online yoga training will be held for the intervention group Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Sexual Dysfunction, Exercise
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2021to 10 Oct 2021
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-35,
- In primiparous pregnant women (18-26 weeks),
- Female Sexual Function Scale (FSFI) score> 22.7,
- Volunteering to participate in research,
- To speak Turkish.
Who cannot join
- Having a disability that makes it difficult for the pregnant woman to do yoga asanas,
- have done yoga Subtraction criterion Not attending the trainings regularly,
- Not attending at least 5 of the trainings
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Haseki Hospital
Sultangazı, Istanbul
Fatma Şule Tanrıverdi, PhD Student, 5413606482, sulebilgic@halic.edu.tr
Aysu Yıldız Karaahmet, PhD Student, 5414679620, aysuyildiz@halic.edu.tr
About this study
Official title: The Effect of Yoga on Sexual Function in Primiparous Pregnants: Single-Blind Randomized Controlled Study
This study was planned as a single blind randomized controlled type in order to examine the effect of yoga on sexual function in primipara pregnant women.150 pregnant women will be randomized.The data will be interviewed online with pregnant women and online yoga training will be held for the intervention group
Read the detailed description
This study was planned as a single blind randomized controlled type in order to examine the effect of yoga on sexual function in primipara pregnant women. The data of the research will be collected through the "Data Collection Form, Female Sexual Function Scale (FSFI)" and The Body Exposure During Sexual Activities Questionnaire (BESAQ), which are created by the researchers by scanning the literature. Research Volunteers who apply to SBU Haseki Training and Research Hospital Pregnancy Outpatient Clinic and meet the sample selection criteria will constitute the sample of the study. In order to determine the minimum sample size required for this study, the power analysis 80% power and α = 0.50 were calculated to include a total of 138 women with a minimum 69 sample size in each group. The intervention and control ratio is 1. However, considering the probability of loss, 150 pregnant women will be randomized. The data will be interviewed online with pregnant women and online yoga training will be held for the intervention group, and the data will be uploaded to the ISM SPSS 22.0 (Statistical Package for the Social Sciences) statistics program; Parametric (Anova and T test) and nonparametric (Mann-Whitney U Test, Kruskal Wallis, Chi Square) statistical methods will be used.
- Conditions
- Pregnancy Related, Sexual Dysfunction, Exercise
- Being tested
- Yoga
- Keywords
- pregnancy, Sexual function, yoga
- Medical subject headings
- Sexual Dysfunction, Physiological, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Breath Awareness Training (5 minutes) Asanas (20 minutes)
- Bending sideways in Mountain Stance
- Standing Pelvic Shaking Warrior Stance II Squatting and malasana (wreath pose) Breath awareness in lotus pose (sitting) Cane pose Fixed Butterfly / Angel Pose
- Sitting wide in Angel Pose Cat Pose Tiger Breath Mudra and meditation (10 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Intervantion | Experimental | Pregnant Yoga Receives: Other: Yoga |
| Control | No intervention | The clinic will receive routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
sexual function
FSFI(FEMALE SEXUAL FUNCTION INDEX)
Measured: 4 weeks
Secondary outcomes (1)
Body ımage
BESAQ (The Body Exposure during Sexual Activities Questionnaire)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start10 Jan 2021
- Primary completion10 Jun 2021 (estimated)
- Study completion10 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Single group
- Model description
- Randomized controlled single blind
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor
- Investigators
- Fatma Şule Tanrıverdi, MsC, Principal investigator, Haseki Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764838
- Sponsor's protocol ID
- Yoga on Sexual Function
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study was planned as a single blind randomized controlled type in order to examine the effect of yoga on sexual function in primipara pregnant women.150 women were randomized. Pregnant women in the intervention group are applied online yoga, and pregnant women in the control group receive clinical routine care.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga on Sexual Function in Primiparous Pregnants: Single-Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04764838
- Acronym / sponsor ID
- Yoga on Sexual Function
- Conditions
- Pregnancy Related, Sexual Dysfunction, Exercise
- Keywords
- pregnancy, Sexual function, yoga
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Jun 2021 (estimated)
- Study completion
- 10 Oct 2021 (estimated)
- First posted
- 21 Feb 2021 (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.
This study was planned as a single blind randomized controlled type in order to examine the effect of yoga on sexual function in primipara pregnant women.150 pregnant women will be randomized.The data will be interviewed online with pregnant women and online yoga training will be held for the intervention group
Detailed description
This study was planned as a single blind randomized controlled type in order to examine the effect of yoga on sexual function in primipara pregnant women. The data of the research will be collected through the "Data Collection Form, Female Sexual Function Scale (FSFI)" and The Body Exposure During Sexual Activities Questionnaire (BESAQ), which are created by the researchers by scanning the literature. Research Volunteers who apply to SBU Haseki Training and Research Hospital Pregnancy Outpatient Clinic and meet the sample selection criteria will constitute the sample of the study. In order to determine the minimum sample size required for this study, the power analysis 80% power and α = 0.50 were calculated to include a total of 138 women with a minimum 69 sample size in each group. The intervention and control ratio is 1. However, considering the probability of loss, 150 pregnant women will be randomized. The data will be interviewed online with pregnant women and online yoga training will be held for the intervention group, and the data will be uploaded to the ISM SPSS 22.0 (Statistical Package for the Social Sciences) statistics program; Parametric (Anova and T test) and nonparametric (Mann-Whitney U Test, Kruskal Wallis, Chi Square) statistical methods will be used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled single blind
| Arm | Type | Receives |
|---|---|---|
| Intervantion | Experimental | Other: YogaPregnant Yoga |
| Control | No intervention | –The clinic will receive routine care |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the ages of 18-35,
Key exclusion criteria (3 listed)
- Having a disability that makes it difficult for the pregnant woman to do yoga asanas,
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 |
|---|---|---|
| YogaBreath Awareness Training (5 minutes) Asanas (20 minutes) * Bending sideways in Mountain Stance * Standing Pelvic Shaking Warrior Stance II Squatting and malasana (wreath pose) Breath awareness in lotus pose (sitting) Cane pose Fixed Butterfly / Angel Pose * Sitting wide in Angel Pose Cat Pose Tiger Breath Mudra and meditation (10 minutes) | Other | Intervantion |
Primary outcome
sexual function
Time frame: 4 weeks
FSFI(FEMALE SEXUAL FUNCTION INDEX)
1 secondary outcome
Body ımage
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: Yes. This study was planned as a single blind randomized controlled type in order to examine the effect of yoga on sexual function in primipara pregnant women.150 women were randomized. Pregnant women in the intervention group are applied online yoga, and pregnant women in the control group receive clinical routine care.
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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.
Fatma Şule Tanrıverdi, MsC principal investigator
Haseki Hospital
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 Pregnancy Related and Sexual Dysfunction, run by Halic 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 5 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 21 Feb 2021. 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 Fatma Şule Tanrıverdi, MsC (5413606482, sulebilgic@halic.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sexual function (time frame: 4 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 21 Feb 2021.