The Effect of IVF Counseling on Psychosocial Well-Being

Not Applicable

Completed

• Conditions: Psychological Distress; Infertility; Infertility, Female; Nurse's Role; Depression, Anxiety
• Interventions: Behavioral: Psychosocial Care

• Registration Number: NCT04703725
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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.

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 Timeline

• Study Start: 2020-02-04
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Primary Completion: 2021-03-16
• Study Completion: 2021-03-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Psychosocial Care	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

Primary Outcome Measures

Name	Time	Method
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.
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
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.
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).

Trial Locations

Locations (1)

İstanbul University-Cerrrahpaşa; 🇹🇷 Istanbul, Turkey