Mandala Activity Accompanied With Two Different Music on Infertility

Sponsor
Istanbul Gedik University (Other)
Overall Status
Completed
CT.gov ID
NCT05839171
Collaborator
(none)
120
1
3
8.3
14.4

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: music and mandala coloring
N/A

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

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Stress Level and the Effect of Mandala Activity Accompanied With Two Different Music on Infertility Women With Embryo Transfer
Actual Study Start Date :
Nov 19, 2021
Actual Primary Completion Date :
Jul 31, 2022
Actual Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Person's Chosen Music + Mandala coloring

Every day for at least 20 minutes/7-10 days

Behavioral: music and mandala coloring
Listening to music and coloring mandalas for women who have undergone embryo transfer and are waiting at home

Experimental: Meditation Music + Mandala coloring

Every day for at least 20 minutes/7-10 days

Behavioral: music and mandala coloring
Listening to music and coloring mandalas for women who have undergone embryo transfer and are waiting at home

No Intervention: Standard care

Every day

Outcome Measures

Primary Outcome Measures

  1. The effect of music and mandala activity on stress level [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.

  2. The effect of music and mandala activity on level of coping with stress [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kerime Derya BEYDAG Istanbul Turkey

Sponsors and Collaborators

  • Istanbul Gedik University

Investigators

  • Study Director: Kerime Derya BEYDAG, https://akademik.yok.gov.tr/AkademikArama/view/viewAuthor.jsp

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
kerime derya beydağ, Assoc. Prof., Istanbul Gedik University
ClinicalTrials.gov Identifier:
NCT05839171
Other Study ID Numbers:
  • DBEYDAG001*
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2023