Posttraumatic GrowthNCT04170569
Yoga on Posttraumatic Growth and Quality of Life
A study testing Yoga in people with Posttraumatic Growth and Quality of Life, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study is to examine the effect of yoga on posttraumatic growth and quality of life. The birth action, which includes positive and negative experiences, can be an important opportunity to achieve posttraumatic growth and improve the quality of life. 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
- Posttraumatic Growth, Quality of Life
- 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
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2017to 19 Jan 2019
- 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
- Having a baby between 2 and 6 months
- First time mom
- No tissue deformity in extremities
Who cannot join
- Any gynecological disease
- Any psychiatric illness
- Using any psychiatric medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Yoga on Posttraumatic Growth and Quality of Life in the Postpartum Period
The objective of this study is to examine the effect of yoga on posttraumatic growth and quality of life. The birth action, which includes positive and negative experiences, can be an important opportunity to achieve posttraumatic growth and improve the quality of life.
This is a experimental model with pretest-posttest control group study. Two hundred and fifty-two women who met the criteria for inclusion in the study made up the research population. Three instruments were used to obtain the research data: Personal Information Form, Posttraumatic Growth Inventory (PTGI) and SF-36 Quality of Life Questionnaire (SF-36).
Read the detailed description
Failure in modern medicine approaches or side effects of treatments and drugs, as well as the woman's anxiety to hurt herself and her baby direct her and her relatives to try complementary therapies. Women should prefer natural ways in coping with these postpartum problems rather than seeking medical advice.
When yoga and meditation, which are included in the group of mind-body-based complementary therapies, are performed in the postpartum period, they will help to relieve tensions and distresses that accumulate during birth, strengthen the pelvic floor, heal perineum, bring reproductive organs back to their prepregnancy condition healthily, provide the mother and the infant a sleep pattern, and have an easier transition to sleep.
- Conditions
- Posttraumatic Growth, Quality of Life
- Being tested
- Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Yoga Practice and Program: Yoga practice consisted of 10 weeks. Yoga practice involved following stages; 5-minute breathing exercises in standing or sitting position, 40-minute postpartum period specific asanas and last 15- minute deep relaxation in lying position were made by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Yoga program was applied. Receives: Behavioral: Yoga |
| Control Group | No intervention | No yoga program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Yoga on Posttraumatic Growth in the Postpartum Period
The posttraumatic growth scale for measure posttraumatic growth;The scale is scored from 0 to 5 and the lowest is 0 and the highest is 105. The higher the scores obtained, the higher the approval from the traumatic experience shows that it is experiencing high growth. There are three sub-dimensions: the change in self-perception of the scale, the change in philosophy of life, and the change in relationship with others.
Measured: 10 weeks
The Effect of Yoga on Quality of Life in the Postpartum Period
SF-36 Quality of life scale for measure the quality of life; The scale is calculated by inverting the items 1, 6, 7, 8, 9d, 9e, 9h, 11b, 11d. Total score is not calculated in the scale. The subscales evaluate health between 0-100 points. 0 indicates "poor health" and 100 indicates "good health.Higher scores obtained from the subscales of the scale indicate that the quality of life level is high.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start19 Oct 2017
- Primary completion19 Jan 2018
- Study completion19 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic GrowthStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Crossover
- Model description
- Randomized Controlled trial with a prospective pretest-posttest experimental model
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Unver, PhD, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170569
- Sponsor's protocol ID
- Inonu University.
- Status last verified
- Nov 2019
- First submitted
- 29 Oct 2019
- Last updated
- 20 Nov 2019
- 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 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga on Posttraumatic Growth and Quality of Life in the Postpartum Period
- ClinicalTrials.gov ID
- NCT04170569
- Acronym / sponsor ID
- Inonu University.
- Conditions
- Posttraumatic Growth, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 19 Jan 2018 (actual)
- Study completion
- 19 Jan 2019 (actual)
- First posted
- 20 Nov 2019 (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 objective of this study is to examine the effect of yoga on posttraumatic growth and quality of life. The birth action, which includes positive and negative experiences, can be an important opportunity to achieve posttraumatic growth and improve the quality of life.
This is a experimental model with pretest-posttest control group study. Two hundred and fifty-two women who met the criteria for inclusion in the study made up the research population. Three instruments were used to obtain the research data: Personal Information Form, Posttraumatic Growth Inventory (PTGI) and SF-36 Quality of Life Questionnaire (SF-36).
Detailed description
Failure in modern medicine approaches or side effects of treatments and drugs, as well as the woman's anxiety to hurt herself and her baby direct her and her relatives to try complementary therapies. Women should prefer natural ways in coping with these postpartum problems rather than seeking medical advice.
When yoga and meditation, which are included in the group of mind-body-based complementary therapies, are performed in the postpartum period, they will help to relieve tensions and distresses that accumulate during birth, strengthen the pelvic floor, heal perineum, bring reproductive organs back to their prepregnancy condition healthily, provide the mother and the infant a sleep pattern, and have an easier transition to sleep.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled trial with a prospective pretest-posttest experimental model
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: YogaYoga program was applied. |
| Control Group | No intervention | –No yoga program. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having a baby between 2 and 6 months
- First time mom
- No tissue deformity in extremities
Key exclusion criteria (3 listed)
- Any gynecological disease
- Any psychiatric illness
- Using any psychiatric medication
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 Practice and Program: Yoga practice consisted of 10 weeks. Yoga practice involved following stages; 5-minute breathing exercises in standing or sitting position, 40-minute postpartum period specific asanas and last 15- minute deep relaxation in lying position were made by the researcher. | Behavioural | Experimental Group |
Primary outcome
The Effect of Yoga on Posttraumatic Growth in the Postpartum Period
Time frame: 10 weeks
The posttraumatic growth scale for measure posttraumatic growth;The scale is scored from 0 to 5 and the lowest is 0 and the highest is 105. The higher the scores obtained, the higher the approval from the traumatic experience shows that it is experiencing high growth. There are three sub-dimensions: the change in self-perception of the scale, the change in philosophy of life, and the change in relationship with others.
The Effect of Yoga on Quality of Life in the Postpartum Period
Time frame: 10 weeks
SF-36 Quality of life scale for measure the quality of life; The scale is calculated by inverting the items 1, 6, 7, 8, 9d, 9e, 9h, 11b, 11d. Total score is not calculated in the scale. The subscales evaluate health between 0-100 points. 0 indicates "poor health" and 100 indicates "good health.Higher scores obtained from the subscales of the scale indicate that the quality of life level is high.
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 20 Nov 2019.
- 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 Posttraumatic Growth and Quality of Life, run by Inonu 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 3 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: finished, as of the sponsor's last update on 20 Nov 2019. 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?
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?
The Effect of Yoga on Posttraumatic Growth in the Postpartum Period (time frame: 10 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 20 Nov 2019.