The Effect of IVF Counseling on Psychosocial Well-Being

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703725
• Other study ID #: 9199
• Status: Completed
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: March 16, 2021

Study information

• Verified date: April 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 16, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Frederiksen Y, Farver-Vestergaard I, Skovgård 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. Review. — View 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. — View Citation

Homan GF, Davies M, Norman R. The impact of lifestyle factors on reproductive performance in the general population and those undergoing infertility treatment: a review. Hum Reprod Update. 2007 May-Jun;13(3):209-23. Epub 2007 Jan 5. Review. — View Citation

Ockhuijsen HDL, van Smeden M, van den Hoogen A, Boivin J. Validation study of the SCREENIVF: an instrument to screen women or men on risk for emotional maladjustment before the start of a fertility treatment. Fertil Steril. 2017 Jun;107(6):1370-1379.e5. doi: 10.1016/j.fertnstert.2017.04.008. Epub 2017 May 10. — View Citation

Van den Broeck U, Emery M, Wischmann T, Thorn P. Counselling in infertility: individual, couple and group interventions. Patient Educ Couns. 2010 Dec;81(3):422-8. doi: 10.1016/j.pec.2010.10.009. Epub 2010 Nov 13. — View 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. Epub 2005 Apr 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening on distress in fertility treatment	Anxiety (state anxiety, trait anxiety), Depression, Social support, Cognitions regarding fertility problems are measured using screening on distress in fertility treatment (SCREENIVF).	Measurement for each group in the beginning of the IVF treatment
Primary	Screening on distress in fertility treatment	Anxiety (state anxiety, trait anxiety), Depression, Social support, Cognitions regarding fertility problems are measured using screening on distress in fertility treatment (SCREENIVF).	Measurement for each group seven days after embryo transfer
Primary	Infertility Stress	Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory	Measurement for each group in the beginning of the IVF treatment
Primary	Infertility Stress	Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory	Measurement for each group seven days after embryo transfer
Primary	Life Quality Scale for Persons with Fertility Problems	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.	Measurement for each group in the beginning of the IVF treatment
Primary	Life Quality Scale for Persons with Fertility Problems	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.	Measurement for each group seven days after embryo transfer
Primary	Subjective Units of Distress Scale	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.	The day follicle development is followed
Primary	Subjective Units of Distress Scale	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.	Egg pick up procedure day
Primary	Subjective Units of Distress Scale	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.	Embryo transfer day