- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07691320
The Effect of Mandala Art Therapy on Surgical Fear and the Stress Hormone (Cortisol) in High-risk Pregnant Women Before Cesarean Section.
The Effect of Mandala Art Therapy Applied Before Cesarean Section on Surgical Fear and Cortisol Levels in High-Risk Nulliparous Women: A Randomized Controlled Trial
연구 개요
상태
개입 / 치료
상세 설명
This randomized controlled trial is designed to investigate the effect of mandala art therapy applied in the preoperative period on surgical fear and cortisol levels in high-risk nulliparous women scheduled for cesarean section. The study will be conducted with participants meeting inclusion criteria and randomly assigned to intervention and control groups using a randomization method.
The intervention group will receive a structured mandala art therapy session prior to cesarean section, while the control group will receive routine preoperative care. Surgical fear levels will be assessed using a validated scale, and physiological stress will be evaluated through salivary cortisol measurements. The primary outcome of the study is the change in surgical fear levels, while the secondary outcome is the change in cortisol levels. Data will be analyzed using appropriate statistical methods to determine the effectiveness of the intervention.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: ESRA GÜNEY, Associate Professor
- 전화번호: +90 5432064063
- 이메일: esra.guney@inonu.edu.tr
연구 연락처 백업
- 이름: Melike TAN ÇELİK, midwife
- 전화번호: +90 5452259635
- 이메일: melike9635@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- The study sample will consist of high-risk nulliparous women scheduled for elective cesarean section on the same day. Participants will be included if they are 18 years of age or older, diagnosed with high-risk pregnancy conditions (e.g., preeclampsia, gestational diabetes, placenta previa, oligohydramnios, etc.), at term pregnancy (37-42 weeks gestation), with a singleton pregnancy, and able to understand and complete the data collection forms.
Exclusion Criteria:
- Women with a diagnosed psychiatric disorder, any condition that impairs communication (such as hearing, visual, or language impairments), those receiving systemic corticosteroid therapy, those with endocrine disorders that may affect cortisol levels, and those with active oral lesions such as aphthous ulcers or other oral mucosal lesions will be excluded from the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Mandala Art Therapy Group
Participants allocated to the intervention group will receive mandala art therapy in addition to standard preoperative care before cesarean section.
The intervention will consist of a single structured mandala coloring session lasting approximately 30-45 minutes and will be administered prior to surgery.
The intervention is intended to reduce preoperative surgical fear and psychological stress.
|
Participants allocated to the intervention group will receive mandala art therapy in addition to standard preoperative care before cesarean section.
The intervention will consist of a single structured mandala coloring session lasting approximately 30-45 minutes and will be administered prior to surgery.
The intervention is intended to reduce preoperative surgical fear and psychological stress.
|
|
간섭 없음: Control Group
Pregnant women in this group will receive routine preoperative care without mandala art therapy.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Surgical Fear
기간: Baseline (before intervention) and immediately prior to cesarean section
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Surgical fear will be measured using a validated surgical fear scale in high-risk nulliparous women undergoing cesarean section.
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Baseline (before intervention) and immediately prior to cesarean section
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Salivary Cortisol Level
기간: Baseline and immediately prior to cesarean section
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Salivary cortisol levels will be measured as a physiological indicator of stress in high-risk nulliparous women undergoing cesarean section.
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Baseline and immediately prior to cesarean section
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Ercan Yılmaz, Professor, İnönü University Turgut Özal Medical Center
- 수석 연구원: Esra GÜNEY, Associate Professor, İnönü University Faculty of Health Sciences
- 연구 책임자: Melike Tan, midwife, İnönü University Faculty of Health Sciences
간행물 및 유용한 링크
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. .