- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04703725
The Effect of IVF Counseling on Psychosocial Well-Being
April 14, 2022 updated by: Ergul Aslan, Istanbul University - Cerrahpasa (IUC)
The Effect of the Counseling on Women in In Vitro Fertilization (IVF) Process on Emotional Capacity and Well-Being
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
85
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
-
-
-
Istanbul, Turkey, 34381
- İstanbul University-Cerrrahpaşa
-
-
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
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.)
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
Infertile women recruited to the experimental group by randomization will be given a counseling program including psychosocial care in addition to routine (drug explanation during the treatment, preparation before the egg pick up and embryo transfer and post operative care).
IVF treatment
|
Other Names:
|
No Intervention: Control Group
Routine (drug explanation during the treatment, preparation before the egg pick up and embryo transfer and post operative care) IVF treatment will be applied to infertile women who are randomized to the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Screening on distress in fertility treatment
Time Frame: Measurement for each group in the beginning of the IVF 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
|
Screening on distress in fertility treatment
Time Frame: Measurement for each group seven days after embryo transfer
|
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
|
Infertility Stress
Time Frame: Measurement for each group in the beginning of the IVF treatment
|
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
|
Infertility Stress
Time Frame: Measurement for each group seven days after embryo transfer
|
Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory
|
Measurement for each group seven days after embryo transfer
|
Life Quality Scale for Persons with Fertility Problems
Time Frame: Measurement for each group in the beginning of the IVF treatment
|
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
|
Life Quality Scale for Persons with Fertility Problems
Time Frame: Measurement for each group seven days after embryo transfer
|
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
|
Subjective Units of Distress Scale
Time Frame: The day follicle development is followed
|
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
|
Subjective Units of Distress Scale
Time Frame: Egg pick up procedure day
|
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
|
Subjective Units of Distress Scale
Time Frame: Embryo transfer day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1093/humupd/dml056. Epub 2007 Jan 5.
- 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.
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 4, 2020
Primary Completion (Actual)
March 16, 2021
Study Completion (Actual)
March 16, 2021
Study Registration Dates
First Submitted
January 6, 2021
First Submitted That Met QC Criteria
January 8, 2021
First Posted (Actual)
January 11, 2021
Study Record Updates
Last Update Posted (Actual)
April 15, 2022
Last Update Submitted That Met QC Criteria
April 14, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9199
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The research article will be shared after publication
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.
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