Breast Milk Odour and Mother's Voice on Pain and Comfort

NCT06609252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-04-15

No results posted yet for this study

Summary

This study will be conducted to examine the effect of breast milk smell and mother's voice on pain and comfort in retinopathy examination in premature infants. The sample of the study will consist of premature infants who are receiving treatment and care in Izmir Provincial Health Directorate Izmir City Hospital Neonatal Intensive Care Unit within the central borders of Izmir province and who comply with the research limitations to be examined for ROP.

Stage 1: The research will start after the ethics committee and institutional permissions are obtained. The group in which the babies will be included will be determined by randomisation method. In the clinic where the research is carried out, ROP examination is performed on a certain day of the week, so the families of premature babies who meet the inclusion criteria will be informed about the research and their verbal and written permissions will be obtained.

Stage 2: On the day of the examination, fresh breast milk will be obtained from the mothers of the babies in the breast milk group. Mothers of premature infants in the mother voice group will be asked to make a voice recording before the examination. 'Introductory Information Form' will be filled out before the procedure.

Stage 3: Video recording will be made to evaluate the pain, stress, comfort and physiological parameters of premature babies. Video recording will be started 2 minutes before the examination. Video recording will continue for 5 minutes after the ROP examination.

Stage 4: Breast milk odour, mother's voice and physiological parameters of the babies in the control group will be recorded 2 minutes before the examination, 2 minutes after the end of the examination and 5 minutes after the end of the examination.

Stage 5: The babies in the breast milk odour group will be made to smell the styrene sponge dripped with their own mother's milk 2 minutes before the procedure.

Stage 6: Babies in the mother's voice group will be made to listen to their own mother's voice 2 minutes before the procedure.

7th Stage: Babies in the control group will be subjected to the routine practice of the clinic.

Stage 8: The videos recorded after the interventions and the scores given to the PIPP, CEQ, and PBQ scales will be evaluated by two independent faculty members who are experts in their fields.

Conditions

  • Pain
  • Breast Milk Odour
  • Comfort

Interventions

OTHER

Breast milk odour

On the day of the study, the mothers of the babies will be contacted and fresh breast milk will be obtained from the mother of each baby. In the study, a sterile sponge will be used to smell the breast milk to the baby. Breast milk will be taken as 2 ml, dripped onto a sterile sponge and held 10 cm away from the baby's nose and sniffed 2 minutes before the examination.

OTHER

Mother voice

Mothers of premature babies in the mother voice group will be given a voice recorder on the day of the study and will be encouraged to express their feelings and thoughts and say what they want to say to their babies and will be asked to talk to their babies as they wish. The mother's voice, which is recorded 2 minutes before the procedure, will be placed approximately 30 cm away from the baby's ear and a loudspeaker will be placed at the foot end so that the baby can listen to the sound.

Sponsors & Collaborators

  • Tarsus University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2025-03-11
Completion
2025-04-11

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06609252 on ClinicalTrials.gov