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The Effect of IVF Counseling on Psychosocial Well-Being

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04703725
Enrollment
85
Registered
2021-01-11
Start date
2020-02-04
Completion date
2021-03-16
Last updated
2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Psychological Distress, Infertility, Female, Depression, Anxiety, Nurse's Role

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.

Interventions

1. First Follow-Up: One of the implementation of the module 2. Second Follow-up: Implementation of the second module; Breathing Exercises and EFT 3. Third Follow-up: Emotional preparation about egg pick up process, individual application of coping methods 4. Fourth Follow-up: Implementation of the second module; Briefing about Breathing Exercises and EFT embryo transfer process 5. Fifth Follow-up: Implementation of the second module; Breathing Exercises and EFT 6. Sixth Follow-up: Individual application of coping methods until the learning process of pregnancy test result 7. 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.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

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.

Intervention model description

Randomized Controlled Experimental Design

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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.)

Design outcomes

Primary

MeasureTime frameDescription
Screening on distress in fertility treatmentMeasurement for each group in the beginning of the IVF treatmentAnxiety (state anxiety, trait anxiety), Depression, Social support, Cognitions regarding fertility problems are measured using screening on distress in fertility treatment (SCREENIVF).
Infertility StressMeasurement for each group in the beginning of the IVF treatmentPersonal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory
Life Quality Scale for Persons with Fertility ProblemsMeasurement for each group in the beginning of the IVF treatmentLife Quality Scale for Persons with Fertility Problems (FertiQol) is used to measure the effect of quality and accessibility of treatment on quality of life.
Subjective Units of Distress ScaleThe day follicle development is followedApplied 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026