The Effect Of White Noise And Therapeutic Touch On Pain And Physiological Parameters In Premature Infants

NCT05395208 | Completed

• 1 other identifier: 2021/99
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Newborns hospitalized with some respiratory problems in the clinic are taken to noninvasive mechanical ventilation support and vascular access is required for some treatments to be applied to these newborns. The presence of nasal cannulas used for noninvasive mechanical ventilation support in newborns causes restlessness, agitation and stress in infants. The uneasiness and stress experienced by babies during vascular access also affects effective vascular access, causing other doses to be delayed or skipped due to treatment doses that are not completed on time. In addition, the pain experienced by babies indirectly affects nurses. It has been reported in many studies that it is effective in reducing the pain experienced by newborns with non-pharmacological methods. Simultaneous white noise will be played and therapeutic touch applied to help touch methods and white noise listening help reduce or control newborns' pain. Many studies have shown that touching to and listening white noise is effective in reducing pain. This study was planned as a randomized controlled experimental study to determine the effect of white noise-accompanied therapeutic touch application on pain level and physiological parameters and noninvasive mechanical ventilation support during peripheral intravenous catheterization in premature infants hospitalized for treatment. Hypothesis 0: The application of therapeutic touch with white noise during peripheral intravenous catheter intervention in premature infants has no effect on the level of pain. Hypothesis 1: White noise-accompanied therapeutic touch application reduces pain level during peripheral intravenous catheter intervention in premature infants. Hypothesis 2: The therapeutic touch application accompanied by white noise during peripheral intravenous catheter intervention in premature infants positively affects physiological parameters.

Conditions

Pain

Outcome Measures

Primary Outcomes (4)

• Pain Score

  NIPS: Newborn Infant Pain Scale was evaluated. The Newborn Infant Pain Scale consists of 6 behavioral parts: facial expression, crying, breathing pattern, arm and leg movements, and alertness. Apart from crying, 2 separate points (0-1 points) are given for other behaviors, and 3 separate points (0-1-2) are given for crying. The total score varies between 0-7. A high score indicates increased pain intensity. According to the scale scoring: 0 Points: No pain, 1-2 Points: Mild pain, 3-4 Points: Moderate pain, 5-7 Points: Severe pain.

  Before intravenous catheter intervention (5 minutes ago)

• Pain Score

  NIPS: Newborn Infant Pain Scale was evaluated. The Newborn Infant Pain Scale consists of 6 behavioral parts: facial expression, crying, breathing pattern, arm and leg movements, and alertness. Apart from crying, 2 separate points (0-1 points) are given for other behaviors, and 3 separate points (0-1-2) are given for crying. The total score varies between 0-7. A high score indicates increased pain intensity. According to the scale scoring: 0 Points: No pain, 1-2 Points: Mild pain, 3-4 Points: Moderate pain, 5-7 Points: Severe pain.

  Intravenous catheter attempt sequence (0th. minute)

• Pain Score

  NIPS: Newborn Infant Pain Scale was evaluated. The Newborn Infant Pain Scale consists of 6 behavioral parts: facial expression, crying, breathing pattern, arm and leg movements, and alertness. Apart from crying, 2 separate points (0-1 points) are given for other behaviors, and 3 separate points (0-1-2) are given for crying. The total score varies between 0-7. A high score indicates increased pain intensity. According to the scale scoring: 0 Points: No pain, 1-2 Points: Mild pain, 3-4 Points: Moderate pain, 5-7 Points: Severe pain.

  Immediately after intravenous catheter intervention (0th minute)

• Pain Score

  NIPS: Newborn Infant Pain Scale was evaluated. The Newborn Infant Pain Scale consists of 6 behavioral parts: facial expression, crying, breathing pattern, arm and leg movements, and alertness. Apart from crying, 2 separate points (0-1 points) are given for other behaviors, and 3 separate points (0-1-2) are given for crying. The total score varies between 0-7. A high score indicates increased pain intensity. According to the scale scoring: 0 Points: No pain, 1-2 Points: Mild pain, 3-4 Points: Moderate pain, 5-7 Points: Severe pain.

  5 minutes after intravenous catheterization

Secondary Outcomes (19)

• Blood pressure Vital Signs

  Before intravenous catheter intervention (5 minutes ago)

• Blood pressure Vital Signs

  Immediately after intravenous catheter intervention (0th minute)

• Blood pressure Vital Signs

  5 minutes after intravenous catheterization

• Oxygen saturation Vital Signs

  Before intravenous catheter intervention (5 minutes ago)

• Oxygen saturation Vital Signs

  Intravenous catheter attempt sequence (0th. minute)

Study Arms (2)

Therapeutic touch group accompanied by white noise

EXPERIMENTAL

* Camera recording was started 5 minutes before intravenous catheter intervention, vital signs and pain were evaluated. * Therapeutic touch application with white noise was started. * Vital signs and pain were evaluated during intravenous catheterization. * Vital signs and pain were evaluated when the intravenous catheter intervention was terminated and 5 minutes later, and the camera recording was stopped.

Behavioral: Therapeutic touch group accompanied by white noise

Control group

NO INTERVENTION

* Camera recording was started 5 minutes before the intravenous catheter intervention, vital signs and pain were evaluated. * No application was made other than intravascular catheter intervention. * Vital signs and pain were evaluated during intravenous catheterization. * Vital signs and pain were evaluated when the intravenous catheter intervention was terminated and 5 minutes later, and the camera recording was stopped.

Interventions

Therapeutic touch group accompanied by white noise BEHAVIORAL

During the intravenous catheter intervention, approximately 15-20 minutes of white noise was applied with therapeutic touch.

Therapeutic touch group accompanied by white noise

Eligibility Criteria

• Age: 32 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• To be in noninvasive mechanical ventilation support,
• Newborns between 32-36 weeks,
• Not having a life-threatening disease,
• No congenital anomalies,
• Appropriate cognitive level and motor development of the newborn,
• The newborn does not have a physical problem,
• Parents' willingness to participate in the research,

You may not qualify if:

• Presence of IV catheter,
• Having a condition that prevents vascular access,
• Those who have circulation problems in the body,
• Using narcotic, sedative opioid and anticonvulsant drugs
• Pharmacological intervention application for the baby's pain during the procedure

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Home/Work

Istanbul, Üsküdar, 34674, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Gülzade Uysal, Assoc. Dr.

  Okan Üniversitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NURSE

Model Details: Randomized Controlled two groups (control groups and intervention group)

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 27, 2022
• Study Start: June 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: January 12, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)