NCT06013826

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

February 17, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

August 22, 2023

Last Update Submit

September 12, 2023

Conditions

Keywords

telenursing, diabetes, pain, fear

Outcome Measures

Primary Outcomes (2)

  • Injection Pain

    In order to identify the pain that occurs during insulin injection in patients, Insulin injection evaluation form was used. The form created by the researcher was used to determine the difficulties that patients face while administering insulin injections. The form consists of a total of 3 sections and 18 questions regarding the presence of pain, finger puncture pain intensity, drug administration pain intensity, injection administration difficulty, insulin dose skipping. In order to evaluate the items in the form in terms of relevance and scope, it was submitted to the opinion of 4 experts working in the unit and working as educators in undergraduate and graduate programs. After the expert opinion, the items were reviewed and the form was finalized in line with the suggestions.

    Through study completion, an average of 1 months

  • Fear

    The Diabetes Fear of Self Injecting and Self-testing Questionnaire-D-FISQ was used to define the fear of self-injection and testing in diabetics. The validity and reliability of the D-FISQ developed by Snoek et al. (1997) for the Turkish population was performed by Çelik and Pınar (2016). D-FISQ, which includes 15 statements, consists of two sub-dimensions: fear of self-injecting (fear of self-injecting-FSI, 6 statements) and fear of self-testing (fear of self-testing-FST, 9 statements).

    Through study completion, an average of 1 months

Study Arms (2)

Experimental

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.

Other: Telenursing

Control

NO 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. 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.

Interventions

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.

Experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Demet İnangil

Istanbul, 34668, Turkey (Türkiye)

Location

Saglik Bilimleri University

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 26856523BACKGROUND
  • 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.

    PMID: 30170422BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusPain

Interventions

Telenursing

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NursingProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • Demet İnangil

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffessor

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 28, 2023

Study Start

February 17, 2022

Primary Completion

June 15, 2022

Study Completion

November 15, 2022

Last Updated

September 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations