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

Primary Purpose

Pain, Acute, Newborn

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
white noise
therapeutic touch
white noise and therapeutic touch
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Acute

Eligibility Criteria

1 Day - 1 Month (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Gülçin Özalp GerçekerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

White noise group

therapeutic touch group

therapeutic touch and white noise group

Control group

Arm Description

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.

Therapeutic touch steps: 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. 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. 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.

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

heart rate
Babies to be included in the study in each group; Until 30 minutes before the start of the procedure, they will be in their beds, in the rest period, where they are not disturbed. All babies; 5 minutes before, during and up to 5 minutes after blood collection. Heart rate will recorded.
oxygen saturation
Babies to be included in the study in each group; Until 30 minutes before the start of the procedure, they will be in their beds, in the rest period, where they are not disturbed. All babies; 5 minutes before, during and up to 5 minutes after blood collection. Oxygen saturation will recorded.

Full Information

First Posted
July 21, 2022
Last Updated
August 31, 2022
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05524337
Brief Title
White Noise and Therapeutic Touch on Pain and Comfort Level in Newborns During Heel Lance
Acronym
noisetouch
Official Title
The Effect of White Noise and Therapeutic Touch on Physiological Parameters, Pain and Comfort Level in Newborns During Heel Blood Collection: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 22, 2023 (Anticipated)
Study Completion Date
July 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Hypotheses H1: Newborns who listen to white noise during heel blood collection feel less pain and have a higher comfort level. H2: Newborns who are treated with therapeutic touch during heel blood collection feel less pain and have a higher comfort level. H3: Newborns who listen to white noise and apply therapeutic touch during heel blood collection feel less pain and have a higher comfort level. H4: There is a difference between the pain and comfort levels of newborns in terms of group, group-time and time according to the intervention applied. Methods Mothers of newborns whose heel blood will be taken will be informed about the research. The mothers will be informed about the fact that heel blood collection is a routine practice, the data will be recorded by the nurse and 2 observers who take heel blood in the study, and they will also be informed about the white noise and therapeutic touch practices to be listened to, and their written consent will be obtained. After obtaining informed written consent, it will be determined which group the newborn belongs to by stratified randomization. Stratified randomization was applied according to gender and week of birth. A standard approach will be applied to all newborns. Standard approach; If the baby is asleep, the heel blood will be taken, he will be woken up, put on a denim bed, his upper extremities will be gently wrapped with a blanket, and the procedure will be performed by the nurse. Babies to be included in the study in each group; Until 30 minutes before the start of the procedure, they will be in their beds, in the rest period, where they are not disturbed. All babies; 5 minutes before, during and up to 5 minutes after blood collection; Observational findings including heart rates, SpO2 values, pain and confort scores will be recorded in the data form. No additional care will be given to ensure physiological stability in all groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Newborn

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
White noise group
Arm Type
Experimental
Arm Description
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.
Arm Title
therapeutic touch group
Arm Type
Experimental
Arm Description
Therapeutic touch steps: 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. 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. 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.
Arm Title
therapeutic touch and white noise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Non-pharmacological intervention will not be made for the baby in the control group,
Intervention Type
Behavioral
Intervention Name(s)
white noise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
therapeutic touch
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
white noise and therapeutic touch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neonatal Infant Pain Scale (NIPS)
Description
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.
Time Frame
5 minutes
Title
The newborn comfort behavior scale
Description
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.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
heart rate
Description
Babies to be included in the study in each group; Until 30 minutes before the start of the procedure, they will be in their beds, in the rest period, where they are not disturbed. All babies; 5 minutes before, during and up to 5 minutes after blood collection. Heart rate will recorded.
Time Frame
10 minutes
Title
oxygen saturation
Description
Babies to be included in the study in each group; Until 30 minutes before the start of the procedure, they will be in their beds, in the rest period, where they are not disturbed. All babies; 5 minutes before, during and up to 5 minutes after blood collection. Oxygen saturation will recorded.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Babies who are 32 weeks and older given to their mothers who were born healthy Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gülçin Özalp Gerçeker, pHD
Phone
05306411368
Email
gulcinozalp@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Duygu Deniz EROL, RN
Phone
05449309951
Email
duygudeniz.erol@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülçin Özalp Gerçeker
Organizational Affiliation
RN, PhD, Assoc. Prof.
Official's Role
Study Director
Facility Information:
Facility Name
Gülçin Özalp Gerçeker
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gülçin Ö Gerçeker
Phone
05306411368
Email
gulcinozalp@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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