The Effect of IVF Counseling on Psychosocial Well-Being

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Completed
CT.gov ID
NCT04703725
Collaborator
(none)
85
1
2
13.3
6.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Psychosocial Care
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled Experimental DesignRandomized Controlled Experimental Design
Masking:
Single (Participant)
Masking Description:
In the single-blind method, subjects do not know which of the experimental or control groups they were selected and therefore which method was applied to them.The researcher knows the subjects selected for the experimental and control groups, and therefore which method was applied to which subjects.
Primary Purpose:
Supportive Care
Official Title:
The Effect of the Counseling on Women in In Vitro Fertilization (IVF) Process on Emotional Capacity and Well-Being
Actual Study Start Date :
Feb 4, 2020
Actual Primary Completion Date :
Mar 16, 2021
Actual Study Completion Date :
Mar 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

Infertile women recruited to the experimental group by randomization will be given a counseling program including psychosocial care in addition to routine (drug explanation during the treatment, preparation before the egg pick up and embryo transfer and post operative care). IVF treatment

Behavioral: Psychosocial Care
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
  • No Intervention: Control Group

    Routine (drug explanation during the treatment, preparation before the egg pick up and embryo transfer and post operative care) IVF treatment will be applied to infertile women who are randomized to the control group.

    Outcome Measures

    Primary Outcome Measures

    1. Screening on distress in fertility treatment [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 [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 [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 [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 İstanbul University-Cerrrahpaşa Istanbul Turkey 34381

    Sponsors and Collaborators

    • Istanbul University-Cerrahpasa

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ergul Aslan, Professor, Istanbul University-Cerrahpasa
    ClinicalTrials.gov Identifier:
    NCT04703725
    Other Study ID Numbers:
    • 9199
    First Posted:
    Jan 11, 2021
    Last Update Posted:
    Apr 15, 2022
    Last Verified:
    Apr 1, 2022
    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 Apr 15, 2022