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Completed

NCT Number: NCT05839171

Mandala Activity Accompanied With Two Different Music on Infertility

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.

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Key information

Conditions

Infertility Coping Behavior Genital Diseases Stress Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kerime Derya BEYDAG

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

music and mandala coloring

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Gedik University

Other

Registry information

Official study title

Stress Level and the Effect of Mandala Activity Accompanied With Two Different Music on Infertility Women With Embryo Transfer

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 3, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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