InfertilityNCT05148273
The Effect of Telehealth Applications on the Level of Anxiety in the Treatment of Infertility
An observational study of Infertility, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- telenursing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Between the ages 20-45
- Female
- Having been diagnosed with infertility
- Should be able to use a smart phone
- Open to communication
Who cannot join
- Not between the ages of 20-45
- Individuals who do not want to be inherited
Trial locations and contacts
1 site in 1 country.
Emel Taşçı Duran, Prof.Dr. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Suleyman Demırel Unıversıty research and practice hospital
Isparta, Center, East Campus, 32200
Başak Demiralp Yavuz, nurse, +905071721836, basakdemiralp1@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility
- Being tested
- telenursing
- Keywords
- Infertility, telehealth, anxiety, consultancy
- Medical subject headings
- Infertility, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telenursingBehavioural
7-24 counseling and daily treatment protocol reminders will be given to the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Demiralp Yavuz, Suleyman Demirel University
- Investigators
- başak demiralp yavuz, nurse, Principal investigator, researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148273
- Sponsor's protocol ID
- TELENURSING and anxıety
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since it is an ongoing thesis work, I do not want to share the data for a while.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Telehealth Applications Applied to Infertile Women During Drug Treatment Procedures on Anxiety Levels: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05148273
- Acronym / sponsor ID
- TELENURSING and anxıety
- Conditions
- Infertility
- Keywords
- Infertility, telehealth, anxiety, consultancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | – | Behavioral: telenursingAfter 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. |
| 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- Between the ages 20-45
- Female
- Having been diagnosed with infertility
- Should be able to use a smart phone
- Open to communication
Key exclusion criteria (2 listed)
- Not between the ages of 20-45
- Individuals who do not want to be inherited
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telenursing7-24 counseling and daily treatment protocol reminders will be given to the intervention group. | Behavioural | intervention |
Primary outcome
beck anxiety scale
Time frame: 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Individual participant dataSharing planned: No. Since it is an ongoing thesis work, I do not want to share the data for a while.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emel Taşçı Duran, Prof.Dr. contact
başak demiralp yavuz, nurse principal investigator
researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Başak Demiralp Yavuz, nurse (+905071721836 ext. +902462113719, basakdemiralp1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
beck anxiety scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.