- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07368556
The Impact of a Nursing Care Program Based on Human Caring Theory on Adolescents With Self-harm
The Effect of a Nursing Care Program Based on Human Caring Theory on Self-Esteem, Coping, and Self-Compassion in Adolescents With Self-Harm
The aim of this study is to examine the effect of a Nursing Care Program based on Human Caring Theory on self-esteem, coping, and self-compassion in adolescents exhibiting self-harming behavior.
Hypotheses of the research:
H1-a: The self-esteem level of adolescents exhibiting self-harm in the intervention group that received the Human Caring Theory-Based Nursing Care Program differed significantly from the control group.
H1-b: The self-compassion level of adolescents exhibiting self-harm in the intervention group that received the Human Caring Theory-Based Nursing Care Program differed significantly from the control group.
H1-c: The coping level of adolescents exhibiting self-harm in the intervention group that received the Human Caring Theory-Based Nursing Care Program differed significantly from the control group.
This study is a randomized, controlled, single-blind experimental design. It will be conducted between March 2026 and March 2027 at the Child and Adolescent Mental Health and Diseases Outpatient Clinic of Antalya City Hospital with 48 adolescents (24 in the intervention group and 24 in the control group) who meet the inclusion criteria. The Human Caring Theory-Based Nursing Care Program will be applied individually and face-to-face to adolescents in the intervention group through structured therapeutic interviews. Data will be collected using a Personal Information Form, the Inventory of Statements About Self-injury, the Rosenberg Self-Esteem Scale, the Coping Scale for Adolescents, and the Short Form of the Self-Compassion Scale. Data analysis will be performed using the Statistical Package for Social Science (SPSS) 31.0 software package. It is believed that the Human Caring Theory-Based Nursing Care Program may be effective in improving self-esteem, self-compassion, and coping skills in adolescents exhibiting self-harm behavior.
Study Overview
Status
Conditions
Detailed Description
Self-harm is when an individual injures or harms themselves in order to cope with or express emotional distress and confusion. Examples of self-harm include attempting to poison oneself by overdosing on drugs or harmful substances, cutting and scratching the skin, self-burning, and punching oneself. Systematic reviews and meta-analyses of various countries, including Turkey, have found that self-harm behavior ranges from 16% to 17.7% and is particularly high among adolescents. Furthermore, systematic reviews and meta-analyses indicate that self-harm is more common in adolescent girls than in adolescent boys, and is higher in Asia. Umbrella reviews, systematic reviews, and meta-analyses show that many factors influence suicidal and self-harm. Self-esteem, self-compassion, and coping skills are some of the risk factors for self-harm.
Self-harm is a strong predictor of suicide attempts, is repetitive, and is one of the leading causes of death. Early intervention for self-harm can reduce the risk of suicide and death later in life. It is emphasized that planned interventions for self-harm should include alternative behavioral skills and problem-solving strategies, address the individual's strengths in collaboration, utilize individualized coping methods and self-care approaches, and be individualized, structured, and limited in duration. Human Caring Theory adopts the approach that each individual is unique and requires a holistic approach, that treatment is possible only with the individual's participation, and that the individual cannot be considered separately from their environment. Accordingly, it may be appropriate and effective for psychiatric nurses caring for adolescents exhibiting self-harm to base their care processes on Human Caring Theory. A review of the literature reveals that studies in nursing with adolescents based on Human Caring Theory are limited, and additionally, no experimental studies with individuals exhibiting self-harm behavior have been found. It is thought that a nursing care program based on the Human Caring Theory can contribute to the development of coping skills, self-compassion, and self-esteem in adolescents exhibiting self-harm, and can also reduce this behavior. The study suggests that this approach may be effective in protecting adolescents with self-harm from the risk of suicidal behavior and life-threatening risks associated with self-harm, and in maintaining their healthy development.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hilal KARA, MSN
- Phone Number: +90 531 370 38 11
- Email: ucanhilal26@gmail.com
Study Contact Backup
- Name: Dudu KARAKAYA, PhD
- Phone Number: +90 505 255 40 56
- Email: dkarakaya07@gmail.com
Study Locations
-
-
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Antalya, Turkey (Türkiye), 07080
- Recruiting
- Antalya City Hospital
-
Contact:
- Hilal KARA, MSN
- Phone Number: +90 531 370 38 11
- Email: ucanhilal26@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
The study will include adolescents who:
- are aged 14-18 years,
- volunteer to participate in the study, and
- have self-harm according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria.
Exclusion Criteria:
- Adolescents with speech, hearing, comprehension, or visual impairments, as well as those receiving psychosocial support during the research process, will not be included in the study.
Sampling Exclusion Criteria:
- Adolescents who did not participate in all interviews
- Were admitted to the Child and Adolescent Psychiatry clinic for treatment during the research process,
- Did not wish to continue participating in the interviews will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group receiving Nursing Care Program based on Human Caring Theory
In addition to routine treatment and follow-up at the Child and Adolescent Mental Health and Diseases Outpatient Clinic, the Human Caring Theory-Based Nursing Care Program will be implemented face-to-face and individually through therapeutic interviews.
|
Adolescents who can be included in the study are determined by interviewing the group of physicians working at the Child and Adolescent Mental Health and Diseases Outpatient Clinic of Antalya City Hospital.
Providing verbal information about the research to adolescents and parents/guardians, obtaining written consent from adolescents and parents/guardians who agree to participate in the research, administering the measurement tools,implementing the Human Caring Theory-Based Nursing Care Program for a total of six weeks, once a week, re-administering the measurement tools, conducting a follow-up measurement after six weeks,terminating the interview.
|
|
Active Comparator: Group receiving routine treatment and follow-up at the polyclinic.
The control group will receive only routine treatment and follow-up at the Child and Adolescent Mental Health and Diseases Outpatient Clinic.
|
Adolescents who can be included in the study are determined by interviewing the group of physicians working at the Child and Adolescent Mental Health and Diseases Outpatient Clinic of Antalya City Hospital.
Providing verbal information about the research to adolescents and parents/guardians, obtaining written consent from adolescents and parents/guardians who agree to participate in the research, administering the measurement tools, application of measurement tools after six weeks, follow-up measurement after six weeks, terminating the interview.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rosenberg Self Esteem Scale (RSE)
Time Frame: six weeks
|
1st, 2nd, and 3rd questions; 4th and 5th questions; and 9th and 10th questions are evaluated together. If a respondent receives points on any two of the first three questions (2 out of 3), they receive one point from this set. If they select one of the options that receives a point in either the 4th or 5th question, they also receive one point from this set. The 9th and 10th questions are evaluated in the same way as the 4th and 5th questions. The 6th, 7th, and 8th questions are each scored individually. Thus, when a respondent receives points from all question sets, the maximum possible total score is 6. |
six weeks
|
|
The Short Form of Self-Compassion Questionnaire
Time Frame: six weeks
|
The Short Form of the Self-Compassion Scale can be administered to middle school and high school students. Items 1, 4, 8, 9, 10, and 11 on the scale are reverse-coded. As the total score obtained from the scale increases, the level of self-compassion also increases. During the adaptation of the scale into Turkish, one item was removed. |
six weeks
|
|
Coping Scale for Adolescents (CSA)
Time Frame: six weeks
|
The scale consists of 11 items. Items 3, 6, 8, and 10 are related to active coping. Items 1, 2, 9, and 11 are related to avoidance coping. Items 4, 5, and 7 are related to negative coping. Each subscale score is obtained by summing the scores of the relevant items. The possible score range is 0-12 for active coping and avoidance coping, and 0-9 for negative coping. Higher scores on the scale indicate more frequent use of the corresponding coping approach. |
six weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dudu KARAKAYA, PhD, Akdeniz University
- Principal Investigator: Hilal KARA, MSN, Akdeniz University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU-SBE-HK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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