Technology Supported Education Program Based on Human Care Theory

Nursing Caries Clinical Trial

Official title:

The Effect of Technology Supported Education Program Based on Human Care Theory on Knowledge, Self-Efficacy, Quality of Life and Anxiety of Parents of Children With Stem Cell Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05438823
• Other study ID #: Akdenizuni
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: September 2023

Study information

• Verified date: June 2022
• Source: Akdeniz University
• Contact: Duygu Altuntas, MSc
• Phone: +0905518627252
• Email: duygualtuntas[@]akdeniz.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hematopoietic stem cell transplantation is applied in the childhood age group for many reasons such as hematological malignancies, immune deficiencies, hemoglobinopathies, bone marrow failures and congenital metabolic diseases. The transplantation process, which requires a long hospitalization process, is an experience that causes anxiety for the child and the caregiver.

Description:

It is known that during the home care process after discharge, parents experience anxiety because they are away from health professionals, and they need information and support in their care needs. This research has two purposes. 1; Developing a technology-supported home care education program (IBK-EBP) (supported by face-to-face education and mobile application) based on Human Theory of Care (IBK) for home care of children with hematopoietic stem cell transplantation. 2; It is to determine the effect of IBK-EBP education program on parents' knowledge, self-efficacy, anxiety level and quality of life. The study was planned in a single-center, follow-up, double-blind, randomized controlled design. The research sample was planned to be composed of 40 parents, 20 of which were interventions and 20 of which were controls. The home care training program, which will be prepared with up-to-date information in line with the literature; It includes face-to-face training sessions and ensuring the continuity of education at home with the mobile application to be developed. The content of the home care training program to be prepared in this context; regulation of the home environment, compliance with treatment, food safety, personal hygiene and care, social environment, planning of school life and progressive relaxation exercises. As part of the training program, parents will be shown a CD of progressive relaxation exercises before the training. Research data will be collected by a nurse other than the researchers, who was not involved in the study. Research data will be collected using the "Parent and Child Identification Form", "Parent's Knowledge Level of Care Assessment Form", "General Self-Efficacy Scale", "Quality of Life Scale for Caregivers of Cancer Patients" and "Spielberger State and Trait Anxiety Inventory". With a technology-supported home care education program to be developed based on the Human Care Theory it is predicted that the knowledge, self-efficacy, quality of life of the parents will increase and the level of anxiety will decrease, by ensuring the ease and continuity of access to information.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Primary care parent of the child (0-18 years old) after HSCT
• Having mobile internet access
• Discharge planned

Exclusion Criteria:

• Parent's failure to attend at least 3 sessions of the training program

Related Conditions & MeSH terms

• Nursing Caries
• Stem Cell Transplantation

Intervention

Other:
• Educational Programe
IBK-EBP will be administered to parents in six sessions in six days. After six days of training, the mobile application will be used by parents for 8 weeks. The frequency of use of the mobile application will be left entirely to the needs of the parents and reminders will be made through the mobile application. In addition, the video used during the face-to-face training, progressive relaxation exercise videos and motivational sentences will also be included in the mobile application.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge	There are 13 questions in the questionnaire prepared in line with the literature. The questions will be answered as "strongly agree", "agree", "undecided", "disagree", "strongly disagree".	1 year
Primary	Self-Efficacy	Generalized Self-Efficacy Scale, developed by Schwarzer and Jarusalem (1995) and validated in Turkish by Aypay (2010), consists of 10 items in total. The response category is a 4-point scale and is scored as "Totally wrong = 1 point", "Slightly correct = 2 points", "Moderately correct = 3 points", "Totally correct = 4 points". There is no inverse item and cut-off point in the scale. The lowest 10 and the highest 40 points are taken from the scale. It is interpreted as "perceived self-efficacy increases as the scale score increases".	1 year
Primary	Quality Life	The Caregiver Quality of Life Index Cancer Scale (CQOLC), developed by Weitzner et al. (1999), aims to measure caregivers' quality of life, including their physical, emotional, familial and social functions. The total score of each sub-dimension and scale in the scale ranges from 0 to 140. In the scale, financial distress, discomfort sub-dimensions and some questions consist of reversed statements. The scale contains a total of 35 items.	1 year
Primary	Anxiety	It consists of 2 subscales, namely state and trait anxiety. State Anxiety Sub-Scale (STAI-S), an individual's at a certain time and under certain conditions; The Trait Anxiety Subscale (STAI-T) usually requires a description of how one feels. The inventory is answered via 4-point scales. The emotions and behaviors expressed in the items of the State Anxiety Sub-Scale are indicated by choosing one of the options "(1) Not at all, (2) A little, (3) A lot and (4) Completely" according to the severity of such experiences. Emotions and behaviors expressed in Trait Anxiety Sub-Scale items are according to their frequency levels; It is marked as (1) Almost Never, (2) Sometimes, (3) Often, and (4) Almost Always.	1 hyear
Secondary	Patient Satisfaction Evaluation Form According to Watson Improvement Processes	Watson is a form developed by Watson et al. (2010) to evaluate IBC-based nursing care. This satisfaction form is not a scale. The form consists of six questions in total. The first five questions are scored between 1 and 7, and are evaluated as never (1) and always (7). The sixth question is in the form of an open-ended question in which the "moments of care" in the given nursing care are evaluated.	1 year