NCT04703725

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

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 4, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2021

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

January 6, 2021

Last Update Submit

April 14, 2022

Conditions

InfertilityPsychological DistressInfertility, FemaleDepression, AnxietyNurse's Role

Outcome Measures

Primary Outcomes (9)

  • 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).

    Measurement for each group in the beginning of the IVF treatment

  • 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).

    Measurement for each group seven days after embryo transfer

  • Infertility Stress

    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

    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

    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

    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

    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

    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

    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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Behavioral: Psychosocial Care

Control Group

NO INTERVENTION

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.

Interventions

Psychosocial CareBEHAVIORAL

1. First Follow-Up: One of the implementation of the module 2. Second Follow-up: Implementation of the second module; Breathing Exercises and EFT 3. Third Follow-up: Emotional preparation about egg pick up process, individual application of coping methods 4. Fourth Follow-up: Implementation of the second module; Briefing about Breathing Exercises and EFT embryo transfer process 5. Fifth Follow-up: Implementation of the second module; Breathing Exercises and EFT 6. Sixth Follow-up: Individual application of coping methods until the learning process of pregnancy test result 7. 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.

Also known as: First Follow-Up, Second Follow-up, Third Follow-up, Fourth Follow-up, Fifth Follow-up, Sixth Follow-up, Seventh Follow-up
Experimental Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who are infertile and receiving if treatment
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • IVF treatmant
  • Women
  • Women aged18-40 years
  • Sign the informed consent form

You may not qualify if:

  • Having a psychiatric diagnosis /
  • Having a situation that prevents communication (language, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University-Cerrrahpaşa

Istanbul, 34381, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 21075589BACKGROUND

  • 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.

    PMID: 26345684BACKGROUND

  • 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.

    PMID: 28501369BACKGROUND

  • 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.

    PMID: 17208948BACKGROUND

  • 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.

    PMID: 15817584BACKGROUND

  • 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.

    PMID: 25631310BACKGROUND

MeSH Terms

Conditions

InfertilityInfertility, FemaleDepressionAnxiety Disorders

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Experimental Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 11, 2021

Study Start

February 4, 2020

Primary Completion

March 16, 2021

Study Completion

March 16, 2021

Last Updated

April 15, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

The research article will be shared after publication

Locations

TU(1)