- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04755270
Virtual Reality-Supported Hypnofertility
February 10, 2021 updated by: Çiğdem Erdemoğlu, Adiyaman University
The Effect of Virtual Reality-Supported Hypnofertility on Fertility Preparedness, Stress and Coping With Stress in Women Having In Vitro Fertilization
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
107
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Adıyaman, Turkey
- Adıyaman University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Having IVF treatment
Exclusion Criteria:
- Having IVF treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: vr-supported hypnofertility
Relaxation, visualization, imagination and affirmation and techniques based on the hypnofertility philosophy were applied to women in the experimental group in four stages
|
techniques of hypnofertility and VR glasses
Other Names:
|
No Intervention: Control
Any initiative was not applied to the control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fertility Preparedness Scale for Women Receiving Fertility Treatment
Time Frame: Day 12
|
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
Time Frame: Day 12
|
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
Time Frame: Day 12
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yeşim Aksoy Derya, Phd, Inonu University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 25, 2019
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
July 10, 2020
Study Registration Dates
First Submitted
January 24, 2021
First Submitted That Met QC Criteria
February 10, 2021
First Posted (Actual)
February 16, 2021
Study Record Updates
Last Update Posted (Actual)
February 16, 2021
Last Update Submitted That Met QC Criteria
February 10, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AdıyamanU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fertilization in Vitro
-
The First Hospital of Jilin UniversityRecruitingFertilization in VitroChina
-
Mỹ Đức HospitalVrije Universiteit BrusselNot yet recruiting
-
Heilongjiang University of Chinese MedicineNot yet recruitingIn Vitro FertilizationChina
-
Organon and CoCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalCompleted
-
Rambam Health Care CampusUnknownFertilization in Vitro
-
IBSA Institut Biochimique SACompletedIn Vitro FertilizationItaly, United Kingdom, Germany, Hungary, Switzerland
-
Bahceci Health GroupUnknownIn-vitro FertilizationTurkey
Clinical Trials on VR Glasses
-
Gemma Via ClaveroCompleted
-
Inonu UniversityInonu UniversityCompleted
-
King Saud UniversityActive, not recruitingCLBP - Chronic Low Back PainSaudi Arabia
-
Zuyderland Medisch CentrumRecruiting
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Anxiety | Anesthesia | Postoperative RecoveryTurkey
-
Alexandria UniversityCompleted
-
Jessa HospitalCompletedAnesthesia, Local | Surgery | Hand InjuriesBelgium
-
Children's Hospital of Fudan UniversityActive, not recruiting
-
Donald O Mutti, OD, PhDCompleted
-
University of Alabama at BirminghamTerminatedConcussion, Mild | Convergence Insufficiency | Accommodation; InsufficiencyUnited States