NCT04755270

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

January 24, 2021

Last Update Submit

February 10, 2021

Conditions

Keywords

in vitro fertilizationhypnofertilitystress

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

vr-supported hypnofertility

EXPERIMENTAL

Relaxation, visualization, imagination and affirmation and techniques based on the hypnofertility philosophy were applied to women in the experimental group in four stages

Device: VR Glasses

Control

NO INTERVENTION

Any initiative was not applied to the control group

Interventions

techniques of hypnofertility and VR glasses

Also known as: techniques of hypnofertility
vr-supported hypnofertility

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Having IVF treatment

You may not qualify if:

  • Having IVF treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adıyaman University

Adıyaman, Turkey (Türkiye)

Location

Related Publications (1)

  • Erdemoglu C, Aksoy Derya Y. The effect of hypnofertility on fertility preparedness, stress, and coping with stress in women having in vitro fertilization: A randomized controlled trial. J Reprod Infant Psychol. 2024 Jul;42(4):569-580. doi: 10.1080/02646838.2022.2156488. Epub 2022 Dec 13.

Study Officials

  • Yeşim Aksoy Derya, Phd

    Inonu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This research was conducted with the randomized control group pretest-posttest trial model.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 24, 2021

First Posted

February 16, 2021

Study Start

February 25, 2019

Primary Completion

June 1, 2020

Study Completion

July 10, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers. Because the institution where the research was conducted does not allow this.

Locations