- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07845123
The Effect of a Mandala Coloring-Based Nursing Intervention on Perceived Nursing Image and Anxiety in Children Hospitalized in a Pediatric Clinic: A Randomized Controlled Trial
The purpose of this study is to evaluate the effect of a mandala coloring-based nursing intervention on perceived nursing image and state anxiety levels in children aged 8-11 years hospitalized in a pediatric clinic.
연구 개요
상세 설명
The study will be conducted as a randomized controlled trial at the Pediatric Clinic of Kilis Alaeddin Yavaşça State Hospital. A total of 64 children meeting the inclusion criteria will be randomly assigned to the intervention (n=32) and control (n=32) groups. Children in the intervention group will receive a mandala coloring-based nursing intervention for 20 minutes once a day for three consecutive days, while the control group will receive routine clinical care. Data will be collected using a Descriptive Information Form, the Children's Perceived Nursing Image Scale, and the State Anxiety Inventory for Children. State anxiety will be evaluated at baseline, on the third day, and before discharge, while perceived nursing image will be evaluated at baseline and before discharge.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Gamze AKAY, 1
- 전화번호: 05314536661
- 이메일: gamzeakay_25@artvin.edu.tr
연구 연락처 백업
- 이름: Elif Simay KOÇ, 2
- 전화번호: +90 507 149 97 46
- 이메일: elifsimay.koc@kilis.edu.tr
연구 장소
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Central
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Kilis, Central, 터키 (Türkiye)
- 모병
- Kilis Prof. Dr. Alaeddin Yavaşca State Hospital, Kilis, Central
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연락하다:
- Elif Simay KOÇ, 2
- 전화번호: +90 507 149 97 46
- 이메일: elifsimay.koc@kilis.edu.tr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Aged between 8 and 11 years
- Hospitalized in the Pediatric Clinic of Kilis Alaeddin Yavaşça State Hospital
- Expected hospitalization for at least three more days based on clinical evaluation and having no clinical impediment to completing the 3-day intervention protocol
- Able to read and write in Turkish with adequate cognitive ability to understand questions
- Willingness of both child and parent to participate, with written informed consent provided by the parent
- Being able to communicate at an adequate level
Exclusion Criteria:
- Inability to complete the 3-day intervention protocol due to early discharge or other reasons
- Deterioration of the child's clinical condition preventing continuation of the application
- Inability to complete data collection or outcome measurement procedures
- Request by the child or parent to withdraw from the study at any stage
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Control Group
Routine clinical care will be applied to the control group. No action will be taken. |
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실험적: Experimental Group
Children will receive a mandala coloring-based nursing intervention for 20 minutes once a day for three consecutive days during hospitalization, and their anxiety and perceived nursing image will be evaluated. |
Children in the intervention group will receive a mandala coloring-based nursing intervention conducted by the researcher for 20 minutes once daily over three consecutive days. The session will take place in the patient's room or a quiet area within the pediatric clinic at a time that does not interfere with routine care. Each child will be provided with an individual mandala coloring book and a set of 12 colored pencils. Prior to the session, brief communication will be established to explain the activity, allowing the child full autonomy over color selection and coloring style without interference. Communication from the researcher will remain neutral, standardized, and age-appropriate. Children in the control group will receive routine clinical care only, with no mandala coloring or other distraction interventions applied. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Introductory Information Form
기간: Baseline
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The Introductory Information Form was prepared by the researchers based on the relevant literature. The form consists of a total of 10 questions designed to assess the sociodemographic characteristics of the children and their parents, as well as information regarding hospitalization. It includes questions concerning variables such as the child's age, gender, grade level, previous hospitalization experience, duration of stay, and reason for admission, as well as the parent's age, education level, employment status, and family type. |
Baseline
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State Anxiety Level
기간: Baseline (Day 1), Day 3 (1 hour after the final intervention session), and Pre-discharge (approximately 1 hour before discharge).
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Assessed using the State Anxiety Inventory for Children (SAIC / STAIC). The scale consists of 20 items scored between 20 and 60, where higher scores indicate higher levels of state anxiety. |
Baseline (Day 1), Day 3 (1 hour after the final intervention session), and Pre-discharge (approximately 1 hour before discharge).
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Perceived Nursing Image
기간: Baseline (Day 1) and Pre-discharge (approximately 1 hour before discharge).
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Assessed using the Children's Perceived Nursing Image Scale. The scale consists of 35 items scored between 35 and 175, where higher scores indicate a more positive perception of the nursing image. |
Baseline (Day 1) and Pre-discharge (approximately 1 hour before discharge).
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gamze AKAY, 1, Artvin Coruh University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .