Virtual Reality-Supported Hypnofertility

Fertilization in Vitro Clinical Trial

Official title:

The Effect of Virtual Reality-Supported Hypnofertility on Fertility Preparedness, Stress and Coping With Stress in Women Having In Vitro Fertilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04755270
• Other study ID #: AdiyamanU
• Status: Completed
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: July 10, 2020

Study information

• Verified date: February 2021
• Source: Adiyaman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research was conducted to determine the effect of virtual reality-supported hypnofertility on fertility preparedness, stress and coping with stress in women having in vitro fertilization. At the end of research It has been determined that initiatives based on the hypnofertility philosophy increase the level of preparedness to fertility, decrease the stress level and provide effective coping with stress in women who had IVF treatment.

Description:

It is estimated that the infertility affects 8-12% of all couples in reproductive age across the world. Various alternative methods were implemented for years for alleviating the stress which was felt by infertile women. The women in the process of infertility treatment make more efforts to be impregnated, their fertility preparedness is negatively affected and they need more psychosocial support. Upon the review of the relevant literature, it is discerned that there was a limited number of studies in which mind-body programs, namely, hypnofertility methods, were applied to the cases of infertility. In this research, in the first meeting with infertile women who would be assigned to the experimental group, the research objective was explained, and their consent to partake in the research was received in written and verbal format and pretest data were obtained. Later during in vitro fertilization, VR-supported hypnofertility treatment initiative which applied to the experimental group was implemented in four stages, namely, 'Stage 1 (the first folliculometry day)', 'Stage 2 (the second folliculometry day)', 'Stage 3 (oocyte retrieval stage)' and 'Stage 4 (embryo transfer stage)'. And posttest data were obtained at the end of last stage. Each process took 20 minutes on average. Meetings with infertile women who were assigned to the control group were held twice. In the first meeting, pretest data were collected. VR-supported hypnofertility treatment initiative was not applied to the control group, and posttest data were collected from the control group via the second meeting held on the same date as the fourth stage of treatment, namely, the day of embryo transfer. It is considered that the stress levels of women who are in the process of having IVF treatment will fall down and hence the fertility preparedness and the ability to cope with infertility stress will be positively affected by virtue of the effective use of hypnofertility method, which is still a new method in Turkey, by midwives and other health professionals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: July 10, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Having IVF treatment

Exclusion Criteria:

• Having IVF treatment

Related Conditions & MeSH terms

• Fertilization in Vitro

Intervention

Device:
• VR Glasses
techniques of hypnofertility and VR glasses

Locations

Country	Name	City	State
Turkey	Adiyaman University	Adiyaman

Sponsors (1)

Lead Sponsor	Collaborator
Adiyaman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertility Preparedness Scale for Women Receiving Fertility Treatment	The scale is used for the assessment of the levels of stress experienced by infertile couples. As a Likert-type scale, it has three sub-scales in relation to personal, marital and social domains and contains a total of 14 items. 'Stress in personal domain' sub-scale contains six items, and the minimum and maximum scores to be obtained from it are successively 0 and 20 points. 'Stress in marital domain' sub-scale has four items, and the minimum and maximum scores to be obtained from it are successively 0 and 14 points. 'Stress in social domain' sub-scale is comprised of four items, and the minimum and maximum scores to be obtained from it are successively 0 and 12 points. A high score to be obtained from the sub-scale refers to the increase in the stress level.	Day 12
Primary	The Copenhagen Multi-centre Psychosocial Infertility Fertility Problem Stress	The scale is used for the assessment of the levels of stress experienced by infertile couples. As a Likert-type scale, it has three sub-scales in relation to personal, marital and social domains and contains a total of 14 items. 'Stress in personal domain' sub-scale contains six items, and the minimum and maximum scores to be obtained from it are successively 0 and 20 points. 'Stress in marital domain' sub-scale has four items, and the minimum and maximum scores to be obtained from it are successively 0 and 14 points. 'Stress in social domain' sub-scale is comprised of four items, and the minimum and maximum scores to be obtained from it are successively 0 and 12 points. A high score to be obtained from the sub-scale refers to the increase in the stress level.	Day 12
Primary	The Copenhagen Multi-centre Psychosocial Infertility Coping Strategy Scale	The scale contains 19 items and has four sub-scales. The minimum and maximum scores to be obtained from the sub-scale of 'active-avoidance' coping method which is comprised of four items are successively 4 and 16 points. The sub-scale of 'active-confronting' coping method contains seven items. The minimum and maximum scores to be obtained from this sub-scale are successively 7 and 26 points. The minimum and maximum scores to be obtained from the sub-scale of 'passive-avoidance' coping method which is comprised of three items are successively 3 and 12 points. The sub-scale of 'meaning-based' coping method contains five items. The minimum and maximum scores to be obtained from this sub-scale are successively 5 and 20 points. A higher score to be obtained from the subscale means that the method is used more when coping with with stress.	Day 12