Clinical trial NCT04703725: The Effect of IVF Counseling on Psychosocial Well-Being
Official title: The Effect of the Counseling on Women in In Vitro Fertilization (IVF) Process on Emotional Capacity and Well-Being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Psychological Distress
Infertility, Female
Depression, Anxiety
Nurse's Role
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Experimental Design
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Screening on distress in fertility treatment
timeFrame: Measurement for each group in the beginning of the IVF treatment
measure: Screening on distress in fertility treatment
timeFrame: Measurement for each group seven days after embryo transfer
measure: Infertility Stress
timeFrame: Measurement for each group in the beginning of the IVF treatment
measure: Infertility Stress
timeFrame: Measurement for each group seven days after embryo transfer
measure: Life Quality Scale for Persons with Fertility Problems
timeFrame: Measurement for each group in the beginning of the IVF treatment
measure: Life Quality Scale for Persons with Fertility Problems
timeFrame: Measurement for each group seven days after embryo transfer
measure: Subjective Units of Distress Scale
timeFrame: The day follicle development is followed
measure: Subjective Units of Distress Scale
timeFrame: Egg pick up procedure day
measure: Subjective Units of Distress Scale
timeFrame: Embryo transfer day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul University-Cerrrahpaşa
Study officials:
References:
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citation: Gameiro S, Boivin J, Dancet E, de Klerk C, Emery M, Lewis-Jones C, Thorn P, Van den Broeck U, Venetis C, Verhaak CM, Wischmann T, Vermeulen N. ESHRE guideline: routine psychosocial care in infertility and medically assisted reproduction-a guide for fertility staff. Hum Reprod. 2015 Nov;30(11):2476-85. doi: 10.1093/humrep/dev177. Epub 2015 Sep 7.
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citation: Verhaak CM, Smeenk JM, van Minnen A, Kremer JA, Kraaimaat FW. A longitudinal, prospective study on emotional adjustment before, during and after consecutive fertility treatment cycles. Hum Reprod. 2005 Aug;20(8):2253-60. doi: 10.1093/humrep/dei015. Epub 2005 Apr 7.
citation: Frederiksen Y, Farver-Vestergaard I, Skovgard NG, Ingerslev HJ, Zachariae R. Efficacy of psychosocial interventions for psychological and pregnancy outcomes in infertile women and men: a systematic review and meta-analysis. BMJ Open. 2015 Jan 28;5(1):e006592. doi: 10.1136/bmjopen-2014-006592.