The Effect of Education Based on Roy Adaptation Model for... | NCT04741867

Studies
The Effect of Education Based on Roy Adaptation Model for Infertile Individuals on Adaptation and Coping With Stress

NCT04741867

Sponsor

Gaziantep Islam Science and Technology University

Status

Unknown status

Last Update Posted

Feb 5, 2021Actual

Enrollment

61Estimated

Phase

Not Applicable

Conditions

Health Education

Interventions

Education

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2021Estimated

Primary Completion Date

Jun 2021Estimated

Completion Date

Oct 2021Estimated

First Submitted Date

Jan 26, 2021

First Submission Date that Met QC Criteria

Feb 3, 2021

First Posted Date

Feb 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2021

Last Update Posted Date

Feb 5, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ayşe Duygu Özbaş, Instructor, Gaziantep Islam Science and Technology UniversityPrincipal Investigator

Lead Sponsor

Gaziantep Islam Science and Technology UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
receiving health education	Experimental	Other: Education
Level of compliance	Experimental	Other: Education
Coping with stress	Experimental	Other: Education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Education	Other	Patients will be educated to determine their level of coping with stress and their adaptation.	Coping with stress Level of compliance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Training effectiveness	The education given will increase adaptation to infertility and coping with existing stress.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-45age difference

Primary infertility

Exclusion Criteria:

- Secondery infertility

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

infertile woman

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ayşe Duygu Özbaş	Contact	905337625707		duyguyildirim75@gmail.com

Overall Officials

Name	Affiliation	Role
Ayşe Duygu Özbaş	Hasan Kalyoncu University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hasan Kalyoncu Üniversitesi		Gaziantep			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006266	Health Education

Ancestor Terms

ID	Term
D000099060	Adherence Interventions
D055118	Medication Adherence
D010349	Patient Compliance
D010342	Patient Acceptance of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004522	Educational Status

Ancestor Terms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

Browse Leaves

Not provided

Browse Branches

Not provided