search
Back to results

The Effect of IVF Counseling on Psychosocial Well-Being

Primary Purpose

Infertility, Psychological Distress, Infertility, Female

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Psychosocial Care
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.)

Sites / Locations

  • İstanbul University-Cerrrahpaşa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).
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).
Infertility Stress
Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory
Infertility Stress
Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 6, 2021
Last Updated
April 14, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
search

1. Study Identification

Unique Protocol Identification Number
NCT04703725
Brief Title
The Effect of IVF Counseling on Psychosocial Well-Being
Official Title
The Effect of the Counseling on Women in In Vitro Fertilization (IVF) Process on Emotional Capacity and Well-Being
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
March 16, 2021 (Actual)
Study Completion Date
March 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Psychological Distress, Infertility, Female, Depression, Anxiety, Nurse's Role

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Experimental Design
Masking
Participant
Masking Description
In the single-blind method, subjects do not know which of the experimental or control groups they were selected and therefore which method was applied to them.The researcher knows the subjects selected for the experimental and control groups, and therefore which method was applied to which subjects.
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial Care
Other Intervention Name(s)
First Follow-Up, Second Follow-up, Third Follow-up, Fourth Follow-up, Fifth Follow-up, Sixth Follow-up, Seventh Follow-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Screening on distress in fertility treatment
Description
Anxiety (state anxiety, trait anxiety), Depression, Social support, Cognitions regarding fertility problems are measured using screening on distress in fertility treatment (SCREENIVF).
Time Frame
Measurement for each group in the beginning of the IVF treatment
Title
Screening on distress in fertility treatment
Description
Anxiety (state anxiety, trait anxiety), Depression, Social support, Cognitions regarding fertility problems are measured using screening on distress in fertility treatment (SCREENIVF).
Time Frame
Measurement for each group seven days after embryo transfer
Title
Infertility Stress
Description
Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory
Time Frame
Measurement for each group in the beginning of the IVF treatment
Title
Infertility Stress
Description
Personal stress, marital stress, and social stress are measured using The Fertility Problem Stress Inventory
Time Frame
Measurement for each group seven days after embryo transfer
Title
Life Quality Scale for Persons with Fertility Problems
Description
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.
Time Frame
Measurement for each group in the beginning of the IVF treatment
Title
Life Quality Scale for Persons with Fertility Problems
Description
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.
Time Frame
Measurement for each group seven days after embryo transfer
Title
Subjective Units of Distress Scale
Description
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.
Time Frame
The day follicle development is followed
Title
Subjective Units of Distress Scale
Description
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.
Time Frame
Egg pick up procedure day
Title
Subjective Units of Distress Scale
Description
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.
Time Frame
Embryo transfer day

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women who are infertile and receiving if treatment
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Facility Information:
Facility Name
İstanbul University-Cerrrahpaşa
City
Istanbul
ZIP/Postal Code
34381
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The research article will be shared after publication
Citations:
PubMed Identifier
21075589
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.
Results Reference
background
PubMed Identifier
26345684
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.
Results Reference
background
PubMed Identifier
28501369
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.
Results Reference
background
PubMed Identifier
17208948
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. doi: 10.1093/humupd/dml056. Epub 2007 Jan 5.
Results Reference
background
PubMed Identifier
15817584
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. doi: 10.1093/humrep/dei015. Epub 2005 Apr 7.
Results Reference
background
PubMed Identifier
25631310
Citation
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.
Results Reference
background

Learn more about this trial

The Effect of IVF Counseling on Psychosocial Well-Being

We'll reach out to this number within 24 hrs