InfertilityNCT05839171
Mandala Activity Accompanied With Two Different Music on Infertility
A study testing music and mandala coloring in people with Infertility and Stress, run by Istanbul Gedik University at 1 site in Turkey (Türkiye).
Trial summary
In this study; In this study, it is aimed to determine the stress level and the effect of the mandala activity, which is applied to two different musical accompaniments, on coping with stress in infertile women who have undergone embryo transfer.The research was carried out as a randomized controlled experimental… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Stress, Coping Behavior
- What is being tested?
- music and mandala coloring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Nov 2021to 31 Jul 2022
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being primary infertile,
- Embryo transfer (ET) has been made, Beta Hcg value measurement is in the waiting phase,
- Not receiving psychological counseling from a specialist (psychologist, psychiatrist),
- Mandala activity, yoga, meditation, acupuncture, etc. to relieve stress. not applying a method,
- Not having difficulties in communicating
- Agree to participate in the research.
Who cannot join
- Being secondary infertile.
- Bleeding, miscarriage, etc. after embryo transfer. to have lived,
- Having difficulties in communicating,
- Applying alternative methods such as mandala activity, yoga, meditation, acupuncture, etc.,
- Receiving psychological counseling from a specialist (psychologist, psychiatrist),
- Not wanting to participate in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress Level and the Effect of Mandala Activity Accompanied With Two Different Music on Infertility Women With Embryo Transfer
In this study; In this study, it is aimed to determine the stress level and the effect of the mandala activity, which is applied to two different musical accompaniments, on coping with stress in infertile women who have undergone embryo transfer.The research was carried out as a randomized controlled experimental study with women who had embryo transfer at Private Samsun Medicana International Hospital IVF Center and Private Samsun VM Medical Park Hospital IVF Center between 01.07.2021 and 31.07.2022. Introductory Information Form, Infertility Stress Scale (PSS), and Infertility Stress Coping Scale (PSSS) were applied to intervention groups with embryo transfer. The intervention group started right after the embryo transfer and performed a mandala activity accompanied by music or meditation music of their own choosing until the day before the BetaHcg test, and the ISS and PSS were repeated one day before the BetaHcg test. Both groups were provided with the application for at least 7-10 days. After embryo transfer to the control group, Introductory Information Form, PSS and PSS were applied, and PSS and PSS were repeated one day before the BetaHCG test, and no intervention was made other than routine practices.
Read the detailed description
In this study; In this study, it is aimed to determine the stress level and the effect of the mandala activity, which is applied to two different musical accompaniments, on coping with stress in infertile women who have undergone embryo transfer.
The research was carried out as a randomized controlled experimental study with women who had embryo transfer at Private Samsun Medicana International Hospital IVF Center and Private Samsun VM Medical Park Hospital IVF Center between 01.07.2021 and 31.07.2022. Introductory Information Form, Infertility Stress Scale (PSS), and Infertility Stress Coping Scale (PSSS) were applied to intervention groups with embryo transfer. The intervention group started right after the embryo transfer and performed a mandala activity accompanied by music or meditation music of their own choosing until the day before the BetaHcg test, and the ISS and PSS were repeated one day before the BetaHcg test. Both groups were provided with the application for at least 7-10 days. After embryo transfer to the control group, Introductory Information Form, PSS and PSS were applied, and PSS and PSS were repeated one day before the BetaHCG test, and no intervention was made other than routine practices.
- Conditions
- Infertility, Stress, Coping Behavior
- Being tested
- music and mandala coloring
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music and mandala coloringBehavioural
Listening to music and coloring mandalas for women who have undergone embryo transfer and are waiting at home
| Study group | Role | What they receive |
|---|---|---|
| Person's Chosen Music + Mandala coloring | Experimental | Every day for at least 20 minutes/7-10 days Receives: Behavioral: music and mandala coloring |
| Meditation Music + Mandala coloring | Experimental | Every day for at least 20 minutes/7-10 days Receives: Behavioral: music and mandala coloring |
| Standard care | No intervention | Every day |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of music and mandala activity on stress level
The COMPI Fertility Problem Stress Scales), The COMPI Fertility Problem Stress Scale, which was validated and reliable in Turkish by Yılmaz , is a 14-item scale that consists of three sub-dimensions and can be applied to both women and men.One of the aims of the study is to reduce the stress level of painting mandala accompanied by music. For this reason, the COMPI scale was filled before the application was made in the first interview with the patients. The patients painted mandala for at least 20 minutes, accompanied by music, every day for 10 days. At the end of the 10th day, the COMPI scale was filled again before the betahcg value was checked.
Measured: 8 month
The effect of music and mandala activity on level of coping with stress
One of the aims of the study is to reduce the stress level of painting mandala accompanied by music. For this reason, the The COMPI Coping Strategy Scales was filled before the application was made in the first interview with the patients. The patients painted mandala for at least 20 minutes, accompanied by music, every day for 10 days. At the end of the 10th day, the The COMPI Coping Strategy Scales was filled again before the betahcg value was checked.
Measured: 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start19 Nov 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gedik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kerime derya beydağ, Istanbul Gedik University
- Investigators
- Kerime Derya BEYDAG, Study director, https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839171
- Sponsor's protocol ID
- DBEYDAG001*
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van der Vennet, R., & Serice, S. Can Coloring Mandalas Reduce Anxiety? A replication study. Journal of the American Art Therapy Association, 2012,29(2), 87-92.
Lee, S. Why Color Mandalas? A Study Of Anxiety-Reducing Mechanisms. Journal of the American Art Therapy Association, 2018,35(1), 35-41.
Kim, J., & Kim, S. (2018).The Effect Of Coloring Mandala On Stress and Relaxation In Women Undergoing In Vitro Fertilization Treatment. Journal Of Korean Academy Of Nursing,48(5), 647-655.
Maleki, F., Shams, J., & Fallahi Khoshknab, M. (2013). The Effect of Coloring Mandala on Anxiety of Infertile Women. Journal of Caring Sciences, 2(3), 189-195.
Ghasemi, M., Dehghani, M., & Tahmasebi, R. (2015). The Effect Of Coloring Mandala On Anxiety And Stress In Infertile Women. International Journal Of Community Based Nursing And Midwifery, 3(3), 214-221.
Jafari, Z., & Zarei, E. (2017). The Effect Of Mandala Coloring On The Stress And Anxiety Of Infertile Women. Journal Of Caring Sciences, 6(2), 141-148.
Curry, N. A., Kasser, T. Can Coloring Mandalas Reduce Anxiety?. Journal Of The American Art Therapy Association,2005, 22(2), 81-85.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Level and the Effect of Mandala Activity Accompanied With Two Different Music on Infertility Women With Embryo Transfer
- ClinicalTrials.gov ID
- NCT05839171
- Acronym / sponsor ID
- DBEYDAG001*
- Conditions
- Infertility, Stress, Coping Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul Gedik UniversityUniversity, hospital or other
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 3 May 2023 (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.
In this study; In this study, it is aimed to determine the stress level and the effect of the mandala activity, which is applied to two different musical accompaniments, on coping with stress in infertile women who have undergone embryo transfer.The research was carried out as a randomized controlled experimental study with women who had embryo transfer at Private Samsun Medicana International Hospital IVF Center and Private Samsun VM Medical Park Hospital IVF Center between 01.07.2021 and 31.07.2022. Introductory Information Form, Infertility Stress Scale (PSS), and Infertility Stress Coping Scale (PSSS) were applied to intervention groups with embryo transfer. The intervention group started right after the embryo transfer and performed a mandala activity accompanied by music or meditation music of their own choosing until the day before the BetaHcg test, and the ISS and PSS were repeated one day before the BetaHcg test. Both groups were provided with the application for at least 7-10 days. After embryo transfer to the control group, Introductory Information Form, PSS and PSS were applied, and PSS and PSS were repeated one day before the BetaHCG test, and no intervention was made other than routine practices.
Detailed description
In this study; In this study, it is aimed to determine the stress level and the effect of the mandala activity, which is applied to two different musical accompaniments, on coping with stress in infertile women who have undergone embryo transfer.
The research was carried out as a randomized controlled experimental study with women who had embryo transfer at Private Samsun Medicana International Hospital IVF Center and Private Samsun VM Medical Park Hospital IVF Center between 01.07.2021 and 31.07.2022. Introductory Information Form, Infertility Stress Scale (PSS), and Infertility Stress Coping Scale (PSSS) were applied to intervention groups with embryo transfer. The intervention group started right after the embryo transfer and performed a mandala activity accompanied by music or meditation music of their own choosing until the day before the BetaHcg test, and the ISS and PSS were repeated one day before the BetaHcg test. Both groups were provided with the application for at least 7-10 days. After embryo transfer to the control group, Introductory Information Form, PSS and PSS were applied, and PSS and PSS were repeated one day before the BetaHCG test, and no intervention was made other than routine practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Person's Chosen Music + Mandala coloring | Experimental | Behavioral: music and mandala coloringEvery day for at least 20 minutes/7-10 days |
| Meditation Music + Mandala coloring | Experimental | Behavioral: music and mandala coloringEvery day for at least 20 minutes/7-10 days |
| Standard care | No intervention | –Every day |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being primary infertile,
- Embryo transfer (ET) has been made, Beta Hcg value measurement is in the waiting phase,
- Not receiving psychological counseling from a specialist (psychologist, psychiatrist),
- Mandala activity, yoga, meditation, acupuncture, etc. to relieve stress. not applying a method,
- Not having difficulties in communicating
Key exclusion criteria (6 listed)
- Being secondary infertile.
- Bleeding, miscarriage, etc. after embryo transfer. to have lived,
- Having difficulties in communicating,
- Applying alternative methods such as mandala activity, yoga, meditation, acupuncture, etc.,
- Receiving psychological counseling from a specialist (psychologist, psychiatrist),
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 |
|---|---|---|
| music and mandala coloringListening to music and coloring mandalas for women who have undergone embryo transfer and are waiting at home | Behavioural | Meditation Music + Mandala coloring, Person's Chosen Music + Mandala coloring |
Primary outcome
The effect of music and mandala activity on stress level
Time frame: 8 month
The COMPI Fertility Problem Stress Scales), The COMPI Fertility Problem Stress Scale, which was validated and reliable in Turkish by Yılmaz , is a 14-item scale that consists of three sub-dimensions and can be applied to both women and men.One of the aims of the study is to reduce the stress level of painting mandala accompanied by music. For this reason, the COMPI scale was filled before the application was made in the first interview with the patients. The patients painted mandala for at least 20 minutes, accompanied by music, every day for 10 days. At the end of the 10th day, the COMPI scale was filled again before the betahcg value was checked.
The effect of music and mandala activity on level of coping with stress
Time frame: 8 month
One of the aims of the study is to reduce the stress level of painting mandala accompanied by music. For this reason, the The COMPI Coping Strategy Scales was filled before the application was made in the first interview with the patients. The patients painted mandala for at least 20 minutes, accompanied by music, every day for 10 days. At the end of the 10th day, the The COMPI Coping Strategy Scales was filled again before the betahcg value was checked.
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 3 May 2023.
- BackgroundVan der Vennet, R., & Serice, S. Can Coloring Mandalas Reduce Anxiety? A replication study. Journal of the American Art Therapy Association, 2012,29(2), 87-92.
- BackgroundLee, S. Why Color Mandalas? A Study Of Anxiety-Reducing Mechanisms. Journal of the American Art Therapy Association, 2018,35(1), 35-41.
- BackgroundKim, J., & Kim, S. (2018).The Effect Of Coloring Mandala On Stress and Relaxation In Women Undergoing In Vitro Fertilization Treatment. Journal Of Korean Academy Of Nursing,48(5), 647-655.
- BackgroundMaleki, F., Shams, J., & Fallahi Khoshknab, M. (2013). The Effect of Coloring Mandala on Anxiety of Infertile Women. Journal of Caring Sciences, 2(3), 189-195.
- BackgroundGhasemi, M., Dehghani, M., & Tahmasebi, R. (2015). The Effect Of Coloring Mandala On Anxiety And Stress In Infertile Women. International Journal Of Community Based Nursing And Midwifery, 3(3), 214-221.
- BackgroundJafari, Z., & Zarei, E. (2017). The Effect Of Mandala Coloring On The Stress And Anxiety Of Infertile Women. Journal Of Caring Sciences, 6(2), 141-148.
- Results publicationCurry, N. A., Kasser, T. Can Coloring Mandalas Reduce Anxiety?. Journal Of The American Art Therapy Association,2005, 22(2), 81-85.
- 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.
Kerime Derya BEYDAG study director
https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music and mandala coloring in people with Infertility and Stress, run by Istanbul Gedik 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 6 inclusion and 6 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 3 May 2023. 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 music and mandala activity on stress level (time frame: 8 month). 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?
On the ClinicalTrials.gov record for NCT05839171, which also lists 7 linked publications.
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 3 May 2023.