DepressionNCT05005546
The Effect of Yoga and Laughter Yoga on Increasing the Psychological Resilience of Mothers
A study testing Yoga and Laughter Yoga in people with Depression and Stress, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: The study will carried out in a randomized controlled trial to determine the effect of yoga and laughter yoga on increasing the psychological resilience of mothers with their babies in the Neonatal Intensive Care Unit Method: The research will be carried out with mothers whose babies are treated in the… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Stress, Anxiety
- What is being tested?
- Yoga and Laughter Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2021to 30 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers who are older than 18 years of age,
- whose gestational week is less than 32 weeks,
- whose baby has been treated in the neonatal intensive care unit for at least one week,
- who have internet access
Who cannot join
- Mothers with a genetic disease or congenital anomaly in their baby
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Yoga and Laughter Yoga on Increasing the Psychological Resilience of Mothers With Their Babies in the Neonatal Intensive Care Unit
Objective: The study will carried out in a randomized controlled trial to determine the effect of yoga and laughter yoga on increasing the psychological resilience of mothers with their babies in the Neonatal Intensive Care Unit
Method: The research will be carried out with mothers whose babies are treated in the neonatal intensive care unit. Mothers will be divided into three groups as yoga (n=20), laughter yoga (n=20) and control (n=20) by block randomization method. Research findings; Data Form will obtained by using "Introductory Characteristics Form", "Depression, Anxiety, Stress Scale (DASS-21)" and "Psychological Resilience Scale".
Read the detailed description
Starting from the 1st week (5-7 days) after the birth, mothers will be given 10 sessions of laughter yoga (laughter group) and yoga (yoga group) twice a week for 45 minutes.DASS-21 and Resilience Scale will be administered to mothers in all groups at 1st, 3rd and 5th weeks.
- Conditions
- Depression, Stress, Anxiety, Psychological Resilience
- Being tested
- Yoga, Laughter Yoga
- Keywords
- Psychological Resilience, Depression, Stress, Anxiety, Nursing
- Medical subject headings
- Depression, Anxiety Disorders
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 mothers in the yoga group
Laughter YogaBehavioural
Laughter Yoga will be applied to mothers in the yoga group
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Yoga | Experimental | Not described Receives: Behavioral: Yoga |
| Experimental: Laughter Yoga | Experimental | Not described Receives: Behavioral: Laughter Yoga |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety, Stress Scale (DASS-21)
It is an assessment tool developed to evaluate the depression, anxiety and stress levels of individuals.
Measured: 0-3 point each item, min 0-max 21 total point each subscale
Psychological Resilience Scale
The scale is a scale developed to determine the psychological resilience of individuals, which enables them to return to their former state after negative events.
Measured: min 0-max 40 point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start8 Aug 2021
- Primary completion1 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Koc Ozkan, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005546
- Sponsor's protocol ID
- 2021/085
- Status last verified
- Jul 2022
- First submitted
- 7 Aug 2021
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga and Laughter Yoga on Increasing the Psychological Resilience of Mothers With Their Babies in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05005546
- Acronym / sponsor ID
- 2021/085
- Conditions
- Depression, Stress, Anxiety, Psychological Resilience
- Keywords
- Psychological Resilience, Depression, Stress, Anxiety, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 8 Aug 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 13 Aug 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.
Objective: The study will carried out in a randomized controlled trial to determine the effect of yoga and laughter yoga on increasing the psychological resilience of mothers with their babies in the Neonatal Intensive Care Unit
Method: The research will be carried out with mothers whose babies are treated in the neonatal intensive care unit. Mothers will be divided into three groups as yoga (n=20), laughter yoga (n=20) and control (n=20) by block randomization method. Research findings; Data Form will obtained by using "Introductory Characteristics Form", "Depression, Anxiety, Stress Scale (DASS-21)" and "Psychological Resilience Scale".
Detailed description
Starting from the 1st week (5-7 days) after the birth, mothers will be given 10 sessions of laughter yoga (laughter group) and yoga (yoga group) twice a week for 45 minutes.DASS-21 and Resilience Scale will be administered to mothers in all groups at 1st, 3rd and 5th weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Yoga | Experimental | Behavioral: Yoga |
| Experimental: Laughter Yoga | Experimental | Behavioral: Laughter Yoga |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mothers who are older than 18 years of age,
- whose gestational week is less than 32 weeks,
- whose baby has been treated in the neonatal intensive care unit for at least one week,
- who have internet access
Key exclusion criteria (1 listed)
- Mothers with a genetic disease or congenital anomaly in their baby
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 mothers in the yoga group | Behavioural | Experimental: Yoga |
| Laughter YogaLaughter Yoga will be applied to mothers in the yoga group | Behavioural | Experimental: Laughter Yoga |
Primary outcome
Depression, Anxiety, Stress Scale (DASS-21)
Time frame: 0-3 point each item, min 0-max 21 total point each subscale
It is an assessment tool developed to evaluate the depression, anxiety and stress levels of individuals.
Psychological Resilience Scale
Time frame: min 0-max 40 point
The scale is a scale developed to determine the psychological resilience of individuals, which enables them to return to their former state after negative events.
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 6 Jul 2022.
- Individual participant dataSharing planned: Yes
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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 and Laughter Yoga in people with Depression and Stress, run by Adiyaman University Research Hospital 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 1 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 6 Jul 2022. 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?
Depression, Anxiety, Stress Scale (DASS-21) (time frame: 0-3 point each item, min 0-max 21 total point each subscale). 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 6 Jul 2022.