NCT04741867

Brief Summary

Psychosocial counseling applied together with infertility treatment programs makes infertile women more resistant to stress, increases the effectiveness of infertility treatments and encourages infertile patients to continue treatment by improving their mental health. It appears that learning adaptation strategies in infertile couples is concurrent with health promotion. In addition to medical treatments, it is aimed to add training to be given in accordance with the Roy Adaptation model, to adapt to the process and infertility, and to control stress in infertile individuals in the management of the process. The study was planned to examine the effect of education based on the roy adaptation model for infertile individuals on adaptation and coping with stress.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

January 26, 2021

Last Update Submit

February 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Training effectiveness

    The education given will increase adaptation to infertility and coping with existing stress.

    3 months

Study Arms (3)

receiving health education

EXPERIMENTAL
Other: Education

Level of compliance

EXPERIMENTAL
Other: Education

Coping with stress

EXPERIMENTAL
Other: Education

Interventions

Patients will be educated to determine their level of coping with stress and their adaptation.

Coping with stressLevel of compliancereceiving health education

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsinfertile woman
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age difference
  • Primary infertility

You may not qualify if:

  • \- Secondery infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu Üniversitesi

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health Education

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Ayşe Duygu Özbaş

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe Duygu Özbaş

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 5, 2021

Study Start

March 1, 2021

Primary Completion

June 1, 2021

Study Completion

October 1, 2021

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations