The Effect of Telehealth Applications on the Level of Anxiety in the Treatment of Infertility

Investigation of the Effects of Telehealth Applications Applied to Infertile Women During Drug Treatment Procedures on Anxiety Levels: A Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility
• Intervention / Treatment: Behavioral: telenursing

Detailed Description

Ethics committee and hospital approval were obtained in order to conduct the study. The sample of the study consists of people who applied to the IVF clinic of Süleyman Demirel University Research and Practice Hospital. The work is planned to be completed between April 2021 and March 2022. In the first meeting with the participants, it is carried out by taking precautions to protect against the COVID 19 pandemic, in cases where it is met face to face. Participants will be divided into groups with 1 to 1 method in randomization. Participants assigned to the intervention group will be given a personal information form and beck anxiety scale before treatment, followed by telehealth service throughout the treatment protocol, and the beck anxiety scale will be repeated at the end of the treatment. In the control group, a personal information form and Beck anxiety scale will be applied before the treatment and will be repeated after the procedure.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Başak Demiralp Yavuz, nurse; Phone Number: +902462113719 +905071721836; Email: basakdemiralp1@gmail.com
• Study Contact Backup: Name: Emel Taşçı Duran, Prof.Dr.; Email: emelduran@sdu.edu.tr

Study Locations

• Turkey
  • Center, East Campus
    • Isparta, Center, East Campus, Turkey, 32200
      • Recruiting
      • Suleyman Demırel Unıversıty research and practice hospital
      • Contact: Başak Demiralp Yavuz, nurse; Phone Number: +905071721836; Email: basakdemiralp1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 7-24 counseling and daily treatment protocol reminders will be given to the intervention group.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Suleyman Demirel University
• Investigators: Principal Investigator: başak demiralp yavuz, nurse, Researcher

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Infertility; anxiety; telehealth; consultancy
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: TELENURSING and anxıety

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Since it is an ongoing thesis work, I do not want to share the data for a while.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No