The Effect of Maternal Voice and Music Therapy on Pain and Stress During Heel Prick Testing in Newborns
The Effect of Maternal Voice and Music Therapy on Pain and Stress During Heel Prick Testing in Newborns: A Randomised Controlled Trial
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
It has been noted that one of the non-pharmacological methods used in effective pain management in children is the mother's voice. Although the mechanism underlying the effect of the mother's voice is not fully understood, it is stated that the mother's voice creates a calming environment for children. Studies have shown that listening to the mother's voice before and after invasive procedures performed on infants and children in intensive care units reduces pain. In a study conducted by Erdoğan et al., it was found that children aged 1-3 years who listened to their mother's voice during painful procedures had lower pain levels, lower heart rates, and higher oxygen saturation. It is emphasized that in critical care settings where mothers cannot be with their babies and children and cannot actively participate in their care, listening to the mother's voice is one of the approaches that can be used as an effective method in pain management.
It is known that non-pharmacological methods are effective in reducing pain in children and that they increase the effectiveness of drugs when used together with analgesics. Non-pharmacological methods are preferred because they are easy to apply and inexpensive, reduce the need for drug administration and thus the risk of side effects. Developing appropriate pain control strategies by knowing the effect of pain and related stress on children is both a medical and ethical responsibility.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Fulya Merve FMK KOS, Assis Prof Dr
- 전화번호: 05300974816
- 이메일: fulya.kos@bilecik.edu.tr
연구 장소
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Turkey
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Bilecik, Turkey, 터키 (Türkiye), 11230
- Bilecik Seyh Edebali University
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연락하다:
- Fulya KOS
- 전화번호: 05300974816
- 이메일: fulya.kos@bilecik.edu.tr
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Newborns within the first 24-48 hours after birth or 7-14 days old
- At least 2 hours after the last painful intervention
- Children whose parents agreed to participate in the study were included.
Exclusion Criteria:
- Presence of hearing impairment
- Absence of Parental Consent Form
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: The Effect of Maternal Voice and Music Therapy on Pain and Stress
The Effect of Maternal Voice and Music Therapy on Pain and Stress During Heel Prick Testing in Newborns
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In the group where Music Therapy will be applied, the heel prick blood test procedure and the study will be explained to the newborn and their parents.
After obtaining consent, music therapy will be applied to the newborn 5 minutes before, during, and after the procedure.
During this time, data will be recorded on a form by the observer.
The song "The Happiest Child," developed by Fulya Merve KOS, a researcher with a Rhythm Therapist™ certificate issued by the Ministry of National Education, will be used in music therapy.
The sound will be adjusted to 45 dB.
The speaker will be placed at the tip of the newborn's foot, approximately 30 cm away from their ear, five minutes before the procedure and played to the child during the procedure.
This sound will be played to the child 5 minutes before, during, and 5 minutes after the heel prick blood test, and data will be recorded by two observers and evaluated using the Newborn Infant Pain Scale (NIPS) and the Newborn Stress Scale.
In the group where the mother's voice will be used, the child's parents will be informed that the mother's voice will be used for pain relief in the study.
For each newborn whose heel prick blood sample is taken by the researcher, the mother's voice will be recorded using a voice recorder.
To play the mother's voice, the voice recorder will be placed 50 cm away from the child and the measurement will be taken.
The sound level of the mother's voice will be set to an average of 45 decibels.
The speaker will be placed at the tip of the newborn's foot, approximately 30 cm away from the ear, five minutes before the procedure and will be played to the child during the procedure.
The child will be played this voice 5 minutes before, during, and 5 minutes after the heel prick blood sample is taken.
Data will be recorded by two observers and evaluated using the Neonatal Infant Pain Scale (NIPS) and the Neonatal Stress Scale.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Neonatal Infant Pain Scale
기간: Baseline / Pre-encounter
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The Neonatal Infant Pain Scale (NIPS) was developed by Lawrence et al. (1993) and adapted into Turkish by Akdovan (1999).
It is a pain assessment scale developed for preterm and newborn infants, which evaluates the behavioural response to pain during invasive procedures.
The total score on the NIPS ranges from 0 to 7, with scores above 3 indicating the presence of pain.
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Baseline / Pre-encounter
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Neonatal Stress Scale
기간: Baseline / Pre-encounter
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The Neonatal Stress Scale was developed by Ceylan and Bolışık (2017) to assess stress levels in premature infants.
The scale consists of 24 items in total, including 8 subgroups covering facial expression, body color, respiration, activity level, soothing ability, muscle tone, extremities, and posture, using a 3-point Likert scale.
Each subgroup is scored between 0 and 2 points.
The minimum score on the scale is 0, and the maximum is 16.
An increase in the score indicates an increased stress level in the infant.
The scale is evaluated through observation.
It is sufficient for the infant to exhibit only one of the behaviors in each cell of the scale for scoring.
When the infant exhibits both of the signs (behaviors) in two different cells during observation (for example, when the infant exhibits signs corresponding to both 1 and 2 points), the highest value is valid.
An infant whose condition is stable and balanced will receive a score of 0 on the scale.
Infants b
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Baseline / Pre-encounter
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- No publications resulting from this study are available at this time as the trial is currently ongoing.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- Bilecik-BSEU4
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual Participant Data (IPD) will not be made publicly available or shared for this study due to ethical considerations regarding participant confidentiality and the explicit terms of the informed consent protocol.
Specifically:
Informed Consent Constraints: The informed consent forms approved by the Institutional Review Board (IRB) / Ethics Committee and signed by the parents/guardians do not include permissions for raw, individual-level data sharing with external third parties or public repositories.
Privacy and Vulnerability: Given that the study population consists of pediatric patients undergoing clinical evaluations, raw IPD contains sensitive demographic and clinical details that could potentially compromise participant anonymity.
De-identified aggregate statistical data, protocol details, and final study findings will be made available through published peer-reviewed journal articles and clinical trial registries upon study completion.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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