White Noise and Therapeutic Touch on Pain and Comfort Level in Newborns During Heel Lance

NCT05524337 | Completed DMC

• 1 other identifier: 6943 GOA
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study was planned to evaluate the effects of listening to white noise and therapeutic touch on physiological parameters, pain and comfort level during the heel blood collection procedure on infants who gave birth at 32 weeks and above and were given to their mothers in Atatürk Training and Research Hospital.

Conditions

Pain, Acute; Newborn

Outcome Measures

Primary Outcomes (2)

• Neonatal Infant Pain Scale (NIPS)

  The Newborn Infant Pain Scale (NIPS) was developed by Lawrence et al. in 1993. Turkish validity and reliability were established by Akdovan in 1999 (Akdovan, 1999). Newborn infant pain scale, facial movements (0; relaxed, 1; restless), crying (0; no crying, 1; groaning, 2; loud crying), breathing (0; relaxed, 1; variable-irregular), arm (0 It is a likert-type scale consisting of 6 parameters: relaxed-free, 1; flexion-extension), leg (0; comfortable-free, 1; flexion-extension) and sleep-wake (0; sleeping-waking peaceful, 1; restless). . The assessment of pain is based on the total score.

  5 minutes

• The newborn comfort behavior scale

  The newborn comfort behavior scale is a Likert type scale developed to evaluate the comfort needs, pain and distress of newborn babies. This scale was developed by Ambuel et al. (1992) to evaluate comfort, pain and stress in newborn babies receiving mechanical ventilator support in the intensive care unit (Ambuel et al., 1992). As a result of the application of this scale, a total score of 6-30 is reached. If the total score obtained as a result of the evaluation is between 9-13, it is emphasized that the baby is comfortable, if it is 14 and above, the baby's comfort level is low and additional interventions may be required to increase comfort.

  5 minutes

Secondary Outcomes (2)

• heart rate

  10 minutes

• oxygen saturation

  10 minutes

Study Arms (4)

White noise group

EXPERIMENTAL

In the white noise group, it will be explained to the mother of the baby that the white noise sound to be used in the research will be used for pain relief. Dr. Harvery Karp's song "The Happiest Baby", consisting of intrauterine sounds only, will be used for white noise. The sound will be set to 45 db. The loudspeaker will be placed on the tip of the foot, approximately 30 cm from the newborns ear, five minutes before the procedure, and will be played to the baby during the procedure. 5 minutes without taking heel blood. Before, during the procedure and 5 minutes after the end of the procedure, this sound will be played to the baby and the data will be recorded by the observer.

Behavioral: white noise

therapeutic touch group

EXPERIMENTAL

Therapeutic touch steps: 1. Before the application, explaining the study and the intervention to be applied to the mother, obtaining the consent of the mother to participate in the study, and filling the introductory information form will be done at this stage. 2. Immobile touching: Hands will be washed and warmed so that they do not disturb the baby. The researcher will support the babys back and hips with one hand, while holding the baby's chest and abdomen with the other hand. In the meantime, the nurse who will take the heel blood will start the process and continue to touch. 3. Compassionate touch: While the practitioners hands are in the same position; He would caress for 1 minute, rest his hands for 30 seconds, then caress again for 1 minute, rest his hands for 30 seconds, and finally continued to caress for 2 minutes. The caressing process was completed by touching it with circular movements of 1 cm diameter in a clockwise direction every 10 seconds.

Behavioral: therapeutic touch

therapeutic touch and white noise group

EXPERIMENTAL

the group where therapeutic touch and white noise will be applied together, after the family is informed about the procedure, white noise will be listened to 5 minutes before, during and 5 minutes after the heel blood collection, and therapeutic touch steps will be applied during this time. Meanwhile, the data will be recorded on the form by the observer.

Behavioral: white noise and therapeutic touch

Control group

NO INTERVENTION

Non-pharmacological intervention will not be made for the baby in the control group,

Interventions

white noise BEHAVIORAL

Dr. Harvery Karp's song "The Happiest Baby", consisting of intrauterine sounds only, will be used for white noise. The sound will be set to 45 db.

White noise group

therapeutic touch BEHAVIORAL

In the group where therapeutic touch will be applied, the heel blood collection procedure and the study will be explained to the family, and after the consent is obtained, the therapeutic touch will be applied to the baby 5 minutes before, during and after the procedure.

therapeutic touch group

white noise and therapeutic touch BEHAVIORAL

the group where therapeutic touch and white noise will be applied together, after the family is informed about the procedure, white noise will be listened to 5 minutes before, during and 5 minutes after the heel blood collection, and therapeutic touch steps will be applied during this time.

therapeutic touch and white noise group

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Babies who are 32 weeks and older given to their mothers who were born healthy

You may not qualify if:

• Newborns 32 weeks and over
• Delivery of the newborn to the mother after birth
• no congenital anomalies or genetic disorders
• The newborn has passed the audiology test
• Obtaining consent form from parent

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Gülçin Özalp Gerçeker

  RN, PhD, Assoc. Prof.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: September 1, 2022
• Study Start: July 1, 2022
• Primary Completion: July 22, 2023
• Study Completion: July 22, 2023
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)