The Effect of Telenursing on the Pain and Fear of Insulin Injection

NCT ID: NCT06013826

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-17

Study Completion Date

2022-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Aim: The aim of the study is to examine the effects of nursing follow-up with telenursing on the pain and fear factors related to self-injection testing in diabetic individuals who are started on insulin therapy for the first time.

Materials and Methods: The research was implemented in a randomized controlled experimental design. The sample consisted of 70 individuals with diabetes who started insulin therapy for the first time in the diabetes polyclinic of a state university hospital in Istanbul between 17 February and 15 November 2022. Individuals who will start insulin therapy for the first time are directed to the diabetes polyclinic. Insulin Injection Application to all patients in the diabetes polyclinic. In line with the Patient Education Content, the ability to administer insulin, the ability to monitor blood glucose levels, medical nutrition therapy, exercise, etc. applied after the training given on the subjects. Data were collected with the Patient Information Form, Diabetic Self-Injection and Fear of Testing Questionnaire Form (D-SFIQ), Insulin Injection Evaluation Form. Patients assigned to the intervention group were given telehealth service for three days for fear of self-injection and testing.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The sample of the study consisted of 70 patients who met the inclusion criteria and agreed to participate. Insulin therapy was evaluated according to the inclusion criteria and those who agreed to participate in the study. 19 doctors and 2 nurses work in the diabetes polyclinic. Individuals who will start insulin therapy for the first time after a doctor's examination are referred to the diabetes polyclinic. The history of the patients who come to the diabetes polyclinic is taken by the diabetes nurse and their physical examination is performed. In the diabetes polyclinic, all patients are taught by the diabetes education nurse, the ability to administer insulin, the ability to monitor blood glucose levels, medical nutrition therapy, exercise, etc. subjects are taught. After the training, the patients are called for control seven days later. However, a nursing follow-up is not applied during this process until it comes to control again. In our study, all patients were given training on insulin administration and testing by subcutaneous route using the Insulin Injection Application Patient Education Content, accompanied by a diabetes polyclinic nurse. In line with the content of the training, it was applied in the form of explaining to all patients with the subcutaneous injection application model, answering the questions of the patients or their relatives with the question-answer method, monitoring the patient while practicing on the model by the researcher, and repeating the training in line with the needs. After the training, all patients who accepted to participate in the study were recorded with the Patient Information Form, as well as their individual characteristics and information about the disease and treatment characteristics. D-FISQ was applied by the face-to-face interview method. The application of the study was continued according to the groups to which they were assigned by randomization (Figure 3.1).

Experimental group intervention Patients who were randomly assigned to the intervention group were informed about the method of the study. The patient was informed that participant would be called before blood glucose measurement and insulin injection for three days to monitor his fear of self-injection and testing. Insulin injection application training was repeated on the first day. Telephone calls made within the scope of tele-health service were recorded in the Telephone Interview Form. During the phone interviews, the questions that the patients wanted to ask were answered. The topics that the patients most frequently asked for support are listed in Table 1. The participant was asked to fill in the Insulin Injection Evaluation Form according to his experience during the three-day home treatment process. At the end of the three-day meeting, the tele-health service was terminated. D-FISQ was repeated to the patients when they came to the hospital for control.

Control group intervention Patients who were randomly assigned to the control group were informed about the method of the study. Telehealth service in the control group was not applied. The participant was asked to fill in the Insulin Injection Evaluation Form according to his experience during the three-day home treatment process. D-FISQ was repeated to the patients when they came to the hospital for control.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nurse's Role

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

Patients who were randomly assigned to the intervention group were informed about the method of the study. The patient was informed that he would be called before blood glucose measurement and insulin injection for three days to monitor his fear of self-injection and testing. Insulin injection application training was repeated on the first day. Telephone calls made within the scope of tele-health service were recorded in the Telephone Interview Form. During the phone interviews, the questions that the patients wanted to ask were answered. He was asked to fill in the Insulin Injection Evaluation Form according to his experience during the three-day home treatment process. At the end of the three-day meeting, the tele-health service was terminated. D-FISQ was repeated to the patients when they came to the hospital for control.

Group Type EXPERIMENTAL

Telenursing

Intervention Type OTHER

Patients who were randomly assigned to the intervention group were informed about the method of the study. The patient was informed that he would be called before blood glucose measurement and insulin injection for three days to monitor his fear of self-injection and testing. Insulin injection application training was repeated on the first day. Telephone calls made within the scope of tele-health service were recorded in the Telephone Interview Form. During the phone interviews, the questions that the patients wanted to ask were answered. He was asked to fill in the Insulin Injection Evaluation Form according to his experience during the three-day home treatment process. At the end of the three-day meeting, the tele-health service was terminated.

Control

Patients who were randomly assigned to the control group were informed about the method of the study. Telehealth service in the control group was not applied. He was asked to fill in the Insulin Injection Evaluation Form according to his experience during the three-day home treatment process. D-FISQ was repeated to the patients when they came to the hospital for control.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telenursing

Patients who were randomly assigned to the intervention group were informed about the method of the study. The patient was informed that he would be called before blood glucose measurement and insulin injection for three days to monitor his fear of self-injection and testing. Insulin injection application training was repeated on the first day. Telephone calls made within the scope of tele-health service were recorded in the Telephone Interview Form. During the phone interviews, the questions that the patients wanted to ask were answered. He was asked to fill in the Insulin Injection Evaluation Form according to his experience during the three-day home treatment process. At the end of the three-day meeting, the tele-health service was terminated.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being 18 years or older,
* Absence of physical, mental inadequacy and communication difficulties,
* Having a diagnosis of type II diabetes,
* Initiation of insulin therapy for the first time,
* Measuring blood sugar at least once a day,
* Self-administration of insulin injection,
* Ability to communicate by phone,
* Not having administered a self-injection of insulin before.

Exclusion Criteria

* Having physical, mental inadequacy and communication difficulties,
* Having a history of allergy,
* Being pregnant,
* Not starting insulin therapy for the first time,
* Not measuring blood sugar at least once a day,
* Not self-administering insulin injection.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul Saglik Bilimleri University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Demet İnangil, PhD

Associate Proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Demet İnangil

Role: STUDY_CHAIR

Saglik Bilimleri Universitesi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Demet İnangil

Istanbul, , Turkey (Türkiye)

Site Status

Saglik Bilimleri University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Souza-Junior VD, Mendes IA, Mazzo A, Godoy S. Application of telenursing in nursing practice: an integrative literature review. Appl Nurs Res. 2016 Feb;29:254-60. doi: 10.1016/j.apnr.2015.05.005. Epub 2015 May 20.

Reference Type BACKGROUND
PMID: 26856523 (View on PubMed)

Peng X, Su Y, Hu Z, Sun X, Li X, Dolansky MA, Qu M, Hu X. Home-based telehealth exercise training program in Chinese patients with heart failure: A randomized controlled trial. Medicine (Baltimore). 2018 Aug;97(35):e12069. doi: 10.1097/MD.0000000000012069.

Reference Type BACKGROUND
PMID: 30170422 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021/0650

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.