Effect of Maternal Voice and Music Therapy on Pain and Physiological Parameters During in Intubated Children

NCT06230211 | Not Yet Recruiting

• 1 other identifier: BSEU-DEU
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Children on mechanical ventilation are given painful stimuli an average of 10-14 times a day, and endotracheal aspiration is one of the procedures that causes the most pain in these children. Effective pain control not only improves the quality of life of children undergoing cardiothoracic surgery, but can also improve clinical outcome. If pain is not alleviated or eliminated with effective interventions during this period, it may cause neurological and behavioral disorders in the future. Excessive and long-term pain, especially as a result of applied interventions, causes behavioral stress and physiological imbalances. Any painful invasive procedure may interfere with the child's behavior, nutrition routine, interaction with the mother, and the child's adaptation to the environment, as well as may cause postoperative complications. In addition, experiencing pain can affect subsequent pain behaviors, causing the child to have a sensitivity to pain throughout his life. Effective pain management is divided into two categories: pharmacological and non-pharmacological. Non-pharmacological pain management strategies in children Pain management is defined as any strategy or technique applied to a child in pain with the aim of reducing the pain experience. Listening to recorded maternal voice and maternal heartbeat, music therapy, white noise are some of the non-pharmacological methods used in children. Studies emphasize that the use of music therapy is an effective method to reduce postoperative pain, ensure better oxygenation and improve physiological parameters in children who have undergone major surgery such as cardiothoracic surgery. It is also emphasized that music therapy reduces respiratory frequency, stabilizes breathing, stimulates the pituitary gland to secrete endorphins, and stabilizes heart rate and blood pressure by reducing catecholamine levels. It is stated 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 explained, it is stated that the mother's voice will create a relaxing environment for children. Studies have shown that listening to the mother's voice before and after invasive interventions on babies and children in the intensive care unit reduces pain. In a study conducted by Erdoğan and his colleagues, they found that the pain levels, heart rates and oxygen saturations of children aged 1-3 who were listened to the mother's voice during painful procedures were lower. It is emphasized that listening to the mother's voice is one of the approaches that can be used as an effective method in pain management in critical care environments where mothers cannot be with their babies and children and cannot actively participate in their care. It is known that non-pharmacological methods are effective in reducing pain in children, and they increase the effectiveness of drugs when used together with analgesics. Non-pharmacological methods are preferred because they are easy to apply and cheap, and they reduce the need for drug administration and thus the risk of side effects. Knowing the impact of pain and related stress on children, developing appropriate pain control strategies is both a medical and ethical responsibility. When the literature is examined, it is thought that there are a limited number of studies examining the effects of mother's voice and music therapy on pain and physiological parameters during the aspiration process in intubated children, and that not examining "mother's voice and music therapy", which directly affects pain and physiological parameters during the aspiration process in intubated children, is an important limitation. In this context, the aim of the study is to examine the effects of mother's voice and music therapy on pain and physiological parameters during the aspiration process in intubated children.

Conditions

Music Therapy; Pain; Physiological Parameters; Mother's Voice

Keywords

Music Therapy; Mother's Voive

Outcome Measures

Primary Outcomes (2)

• Descriptive Information Form

  The form prepared by the researchers in line with the literature consists of 19 questions including socio-demographic characteristics, information about the child's disease, and the parent's pain perception. This form will also record the child's physiological parameters (heart rate, arterial blood pressure, respiratory rate and oxygen saturation) during the painful procedure. (0-1 year old pulse: 80\<pulse value\<160, 1-3 years old pulse: 80\<pulse value\<130, The normal blood pressure limit for a 2-year-old child is 92/44 mmHg. oxygen saturation\>95, Respiratory rate: 30 - 35 in newborn babies, 25-30 in 2-year-old children.)

  one year

• FLACC (Face, Legs, Arms, Cry, Consolability) Pain Scale

  The abbreviation FLACC consists of the initials of the words face, legs, activity, cry and consolability.The FLACC pain scale evaluates five behavioral domains (infant-child facial expression, leg mobility, activity, crying, and consolability) with scores ranging from 0 to 2 for each item. Min. 0 and max. 10 points can be collected. It is stated that as the score increases, the pain level increases, and as it decreases, there is less pain. In scoring, 0 points indicate no pain, 1-3 points indicate mild pain, 4-6 points indicate moderate pain, and 7-10 points indicate severe pain. The validity and reliability of the FLACC pain scale in our country was determined. This scale can be applied observationally by health professionals.

  one year

Study Arms (2)

music therapy

EXPERIMENTAL

In the group where music therapy will be applied, the endotracheal aspiration and study to be performed will be explained to the child's family, and after obtaining consent, the music therapy applied to the child will be applied 5 minutes before, during and after the procedure. Meanwhile, the data will be recorded on the form by the observer. The song "The Happiest Child", developed by creating rhythms by Fulya Merve KOS, one of the researchers who has the RhythmotherapistTM 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 end of the foot, approximately 30 cm from the child's ear, five minutes before the procedure and will be played to the child during the procedure.

Other: Music Therapy

Mother's voice

EXPERIMENTAL

In the group where the mother's voice will be listened to, it will be explained to the child's parents that the mother's voice will be used for pain relief in the research. In the study, the researcher will take a voice from the mother of each child admitted to intensive care and record it on a voice recorder. Measurements will be made by placing the voice recorder 50 cm closer to the child to listen to the mother's voice. The volume of the mother's voice will be adjusted to an average of 45 decibels. The speaker will be placed at the end of the foot, approximately 30 cm from the child's ear, five minutes before the procedure and will be played to the child during the procedure.

Other: Maternal Voice

Interventions

Music Therapy OTHER

Effect of Maternal Voice and Music Therapy on Pain and Physiological Parameters During the Suction Procedure in Intubated Children: Randomized Controlled Study

music therapy

Maternal Voice OTHER

Effect of Maternal Voice and Music Therapy on Pain and Physiological Parameters During the Suction Procedure in Intubated Children: Randomized Controlled Study

Mother's voice

Eligibility Criteria

• Age: 2 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children must be between the ages of 2 - 36 months
• Having Passed the Newborn Audiology Test
• Requiring endotracheal aspiration,
• The patient's hemodynamic parameters monitored on the monitor are stable,
• hours have passed since the last painful attempt
• Children whose parents agreed to participate in the study were included in the study.

You may not qualify if:

• Having an auditory disorder
• Lack of Parental Consent Form

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

MeSH Terms

Conditions

Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 30, 2024
• Study Start: February 2, 2024
• Primary Completion: January 20, 2025
• Study Completion: March 25, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share