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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05148273
• Other study ID #: TELENURSING and anxiety
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: November 2021
• Source: Suleyman Demirel University
• Contact: Basak Demiralp Yavuz, nurse
• Phone: +905071721836
• Email: basakdemiralp1[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
Turkey	Suleyman Demirel University research and practice hospital	Isparta	Center, East Campus

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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