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NCT Number: NCT04703725

The Effect of IVF Counseling on Psychosocial Well-Being

In this study, İt was aimed to determination of the effect of counseling given in accordance with the Roy Adaptation Model in women in the in vitro fertilization (IVF) process on emotional capacity and well-being.

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Key information

Conditions

Infertility Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Anxiety Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility, Female Mental Disorders Nurse's Role Psychological Distress Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul University-Cerrrahpaşa

Istanbul, 34381, Turkey (Türkiye)

About this study

The study will be conducted in the Infertility clinic of a medical school hospital. The study included women receiving IVF treatment. In the pre-initial evaluation, "Introductory Information Form, Screening on distress in fertility treatment (SCREENIVF), Infertility Stress, Life Quality Scale for Persons with Fertility Problems(FertiQol), Subjective Units of Distress Scale-SUD application is planned. A "Consultancy Program" will be applied to the experimental group in the form of two modules in addition to drug applications, egg pick up and embryo transfer before, during and after clinical routine health care. The first module of the counseling program is the definition of infertility, the treatment process, its effects on the life process and coping methods. The second module includes the application of breath awareness and Emotional Freedom Technique (EFT) within the scope of coping methods with infertility stress. Emotional Freedom Technique-EFT is an energy psychotherapy based on the principle that each limiting thought, disturbing emotion and memory of an individual disrupts the energy flow in the body and creates congestion. This technique, the stimulation on the meridian system by focusing on the thought, disturbing emotion or memory that prevents the individual (often by touching) regulates the energy flow and provides the individual to relax. With breath awareness, beneficial results can be obtained, such as physical, sensory and mental control, life-facilitating techniques, individual and social awareness, re-existence and raising the level of consciousness. Within the scope of the counseling program, a total of seven follow-ups will be made, five-to-one, via two phone calls. On the day of follicle development (2nd Follow-up), Egg Pick up Procedure (4th Follow-up) and Embryo transfer (5th Follow-up), the patient will be given breathing exercises and EFT and Subjective Units of Distress Scale will be scored. The control group will continue clinical routine health care and will be followed up on the first day of IVF treatment (1st follow-up) and on the seventh day of embryo transfer (2nd follow-up). For ethical reasons, a consultancy program will be applied to the control group after the second follow-up. Data collection tools will be applied again to both groups in the final evaluation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • IVF treatmant
  • Women
  • Women aged18-40 years
  • Sign the informed consent form

Exclusion criteria

  • Having a psychiatric diagnosis /
  • Having a situation that prevents communication (language, etc.)

Treatment and study plan

Psychosocial Care

Behavioral
  • First Follow-Up: One of the implementation of the module
  • Second Follow-up: Implementation of the second module; Breathing Exercises and EFT
  • Third Follow-up: Emotional preparation about egg pick up process, individual application of coping methods
  • Fourth Follow-up: Implementation of the second module; Briefing about Breathing Exercises and EFT embryo transfer process
  • Fifth Follow-up: Implementation of the second module; Breathing Exercises and EFT
  • Sixth Follow-up: Individual application of coping methods until the learning process of pregnancy test result
  • Seventh Follow-up: Providing information about the first periods of pregnancy after treatment resulting in pregnancy and providing information about the psychosocial problems that may be encountered. Identifying psychosocial problems that may be encountered after unsuccessful treatment and individual application of coping methods to help cope.

Other names: First Follow-Up, Second Follow-up, Third Follow-up, Fourth Follow-up, Fifth Follow-up, Sixth Follow-up, Seventh Follow-up

Primary outcomes

  1. Screening on distress in fertility treatment

    Time frame: Measurement for each group in the beginning of the IVF treatment

    Anxiety (state anxiety, trait anxiety), Depression, Social support, Cognitions regarding fertility problems are measured using screening on distress in fertility treatment (SCREENIVF).

  2. Screening on distress in fertility treatment

    Time frame: Measurement for each group seven days after embryo transfer

    Anxiety (state anxiety, trait anxiety), Depression, Social support, Cognitions regarding fertility problems are measured using screening on distress in fertility treatment (SCREENIVF).

  3. Infertility Stress

    Time frame: Measurement for each group in the beginning of the IVF treatment

    Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory

  4. Infertility Stress

    Time frame: Measurement for each group seven days after embryo transfer

    Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory

  5. Life Quality Scale for Persons with Fertility Problems

    Time frame: Measurement for each group in the beginning of the IVF treatment

    Life Quality Scale for Persons with Fertility Problems (FertiQol) is used to measure the effect of quality and accessibility of treatment on quality of life.

  6. Life Quality Scale for Persons with Fertility Problems

    Time frame: Measurement for each group seven days after embryo transfer

    Life Quality Scale for Persons with Fertility Problems (FertiQol) is used to measure the effect of quality and accessibility of treatment on quality of life.

  7. Subjective Units of Distress Scale

    Time frame: The day follicle development is followed

    Applied to the experimental group. Before starting the application in energy therapies, the problem is evaluated with the severity of the discomfort. It is the subjective evaluation of the discomfort felt by the individual.

  8. Subjective Units of Distress Scale

    Time frame: Egg pick up procedure day

    Applied to the experimental group.Before starting the application in energy therapies, the problem is evaluated with the severity of the discomfort. It is the subjective evaluation of the discomfort felt by the individual.

  9. Subjective Units of Distress Scale

    Time frame: Embryo transfer day

    Applied to the experimental group.Before starting the application in energy therapies, the problem is evaluated with the severity of the discomfort. It is the subjective evaluation of the discomfort felt by the individual.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Effect of the Counseling on Women in In Vitro Fertilization (IVF) Process on Emotional Capacity and Well-Being

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2021
Registry last updated
Apr 15, 2022

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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