NCT05148273

Brief Summary

It is expected that 84% natural pregnancy will occur at the end of the first 12 months of sexual intercourse without the use of contraceptive methods.The lack of natural fertility is under the influence of multiple factors. These factors can be summarized as age, past infections, genetic factors, anatomical structural disorders, environmental toxins, occupational exposure, lifestyle and sexually transmitted infections.Severe psychological stress, anxiety and depression are encountered in the diagnosis, treatment method and management of the related process in couples who are faced with the diagnosis of infertility. With the telehealth service that came to the fore in the world in the 1950s, nurses use it in the management of many treatment processes such as infertility treatment, with the roles of managing the information collection process, making decisions with the information they receive, and transmitting information on patients who are far away and need constant follow-up. Assisted reproductive technologies, which are the current treatment method of infertility, have been used effectively for thirty years. Anxiety control is important in the success of treatment in the treatment process, which is both costly and stressful. Providing 24/7 hours of counseling by using telehealth methods contributes to the reduction of this anxiety.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

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

Study Start

First participant enrolled

March 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

December 8, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

November 4, 2021

Last Update Submit

November 24, 2021

Conditions

Keywords

Infertilitytelehealthanxietyconsultancy

Outcome Measures

Primary Outcomes (1)

  • beck anxiety scale

    The intervention group will be evaluated with the Beck anxiety scale at the beginning of the treatment. Afterwards, the patient who was given telehealth service throughout the treatment will be compared by applying the Beck anxiety scale again at the end of the treatment. The control group will be compared by applying the Beck anxiety scale before and after the treatment.

    1 year

Study Arms (2)

intervention

After the selection process with 1 to 1 randomization method, a personal information form and Beck anxiety scale will be applied to the women selected for the case group on the day of the initiation of treatment with assisted reproductive techniques interview. Then, within an average of 10 days, there is a treatment procedure including planned drug use, messages containing drug doses, drug use, drug administration, follicle count, reminder of the times of operations such as OPU, IUI, ET, and motivational issues. Medication use, time, date, dose, application form and motivational sentences will be sent every day through the WhatsApp application. The Beck anxiety scale will be repeated on the day of IUI and ET procedures, and the effect of telehealth practices on the anxiety levels of women undergoing infertility treatment will be evaluated. During the study, the participants will be able to reach the researcher from their mobile phones whenever they want.

Behavioral: telenursing

control

In the first interview at the beginning of the treatment protocol with assisted reproductive techniques, a personal information questionnaire and beck anxiety scale will be applied to the control group selected by the 1-to-1 randomization method. Afterwards, the Beck anxiety scale will be applied again at the end of the treatment without any intervention.

Interventions

telenursingBEHAVIORAL

7-24 counseling and daily treatment protocol reminders will be given to the intervention group.

intervention

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAs a gender, it should carry the phenomena of the female gender anatomically and psychologically.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study consists of infertile women between the ages of 20-45 who applied to the in vitro fertilization clinic of the Süleyman Demirel University Research and Application Hospital in Isparta, Turkey.

You may qualify if:

  • Between the ages 20-45
  • Female
  • Having been diagnosed with infertility
  • Should be able to use a smart phone
  • Open to communication

You may not qualify if:

  • Not between the ages of 20-45
  • Individuals who do not want to be inherited

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Demırel Unıversıty research and practice hospital

Isparta, Center, East Campus, 32200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

InfertilityAnxiety Disorders

Interventions

Telenursing

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

NursingProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • başak demiralp yavuz, nurse

    researcher

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Başak Demiralp Yavuz, nurse

CONTACT

Emel Taşçı Duran, Prof.Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 4, 2021

First Posted

December 8, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

June 1, 2022

Last Updated

December 8, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Since it is an ongoing thesis work, I do not want to share the data for a while.

Locations