NCT05413629

Brief Summary

In the study, it is aimed to reduce the infertility stress level of women undergoing infertility treatment, to increase the level of coping with infertility stress, to increase infertility self-efficacy, to evaluate the usability of web-based education in the field of infertility, to increase the effectiveness and quality of education by integrating web-based education into the nursing care process, and continuous traceability, to prevention of possible wrong treatment process management in the field of infertility, to prevention of possible loss of cycles and to prevention the material and moral couple from being adversely affected by this process. Method: The study was planned to be carried out between 20.01.2022 and 01.06.2023 with women between the ages of 23-39 who applied to Düzce University Health Practice and Research Center, Infertility Polyclinic. In the research, the Solomon four-group design sample design consisting of two experimental and two control groups will be used. The study planned to consist of a total of 132 patients, 33 patients in each group, taking into account possible data losses. By design, all of the pre-test and post-test measurement tools will be applied to the first experimental and control group, and only the post-test measurement tools will be applied to the second experimental and control group. Randomization will be applied in determining the experimental and control groups. The data will be collected using Personal Information Form (Appendix-1), Infertility Stress Scale (ISS) (Appendix 2), Coping with the Infertility Stress Scale (CISS) (Appendix-3), and Infertility Self-Efficacy Scale - Short Form (ISE-SF) (Appendix 4). Research data will be collected in approximately day 24 to 27 days for each patient from the initiation of Controlled Ovarian Stimulation (COS) treatment to pregnancy determination of patients planned for intrauterine insemination (IUI) treatment. Web-based training is 60 minutes in total, including 4 modules. The web-based training content includes general information about fertility, infertility diagnosis-treatment methods, drugs used in IUI treatment and its application, and issues to be considered after IUI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 9, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

May 9, 2022

Last Update Submit

February 22, 2024

Conditions

Infertility, FemaleEducational ProblemsIntrauterine Insemination

Outcome Measures

Primary Outcomes (2)

  • Infertility Stress Scale

    The level of infertility stress assessed by Infertility Stress Scale (ISS). The scale consists of 3 sub-dimensions. The total minimum score that can be obtained from the scale is 0 and the total maximum score is 46. As the score obtained from the scale increases, the stress level of the individual increases and as the score decreases, the stress level decreases.

    24 to 27 days

  • Coping with the Infertility Stress Scale

    The level of coping with infertility stress assessed by Coping with the Infertility Stress Scale (CISS). The scale consists of 4 sub-dimensions. The total minimum score that can be obtained from the scale is 19 and the total maximum score is 74. As the score obtained from the scale increases, the individual copes better with stress, and as it decreases, the individual copes less well.

    24 to 27 days

Secondary Outcomes (1)

  • Infertility Self-Efficacy Scale - Short Form

    24 to 27 days

Study Arms (4)

Group1 (n=33)

NO INTERVENTION

Control 1: Pretest negative and post test positive group

Group 2 (n=33)

NO INTERVENTION

Control 2: Pretest positive and post test positive

Group 3 (n=33)

EXPERIMENTAL

Experimental 1: Pretest negative and post test positive

Other: Web-based patient education for the intrauterine insemination (IUI) treatment process

Group 4 ( n=33)

EXPERIMENTAL

Experimental 2: Pretest positive and post test positive

Other: Web-based patient education for the intrauterine insemination (IUI) treatment process

Interventions

Web-based patient education for the intrauterine insemination (IUI) treatment processOTHER

Web-based training is 60 minutes in total, including 4 modules. The web-based training content includes general information about fertility, infertility diagnosis-treatment methods, drugs used in IUI treatment and its application, and issues to be considered after IUI.

Group 3 (n=33)Group 4 ( n=33)

Eligibility Criteria

Age23 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Applying to Düzce University Health Practice and Research Center Infertility Polyclinic
  • Primary infertility,
  • Controlled Ovarian Hyperstimulation (COH) planned for the treatment of intrauterine insemination (IUI),
  • Having the equipment (mobile phone, computer, tablet, internet) to access web-based education,
  • No chronic disease,
  • No diagnosed psychiatric disease,
  • Agreeing to participate in the research,
  • Having the ability to understand and comprehend the questionnaires

You may not qualify if:

  • Controlled Ovarian Hyperstimulation (COH) is not planned in the treatment of intrauterine insemination (IUI),
  • Give up treatment,
  • Not having the equipment (mobile phone, computer, tablet, internet) to access web-based education,
  • Having a chronic disease,
  • Having a diagnosed psychiatric disease,
  • Those who do not agree to participate in the research,
  • Those who do not have the ability to understand and comprehend the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hilal Karadeniz

Düzce, 81620, Turkey (Türkiye)

Location

Related Publications (1)

  • Yalazi RO, Demirci N. The effect of bladder training with mobile application on quality of life and sexual satisfaction in women with overactive bladder: randomized controlled study. World J Urol. 2025 Sep 25;43(1):573. doi: 10.1007/s00345-025-05917-6.

    PMID: 40996496DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Nurdan Demirci, Prof.

    Duzce University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Solomon four-group, randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2022

First Posted

June 10, 2022

Study Start

April 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations

TU(1)