The Effect of Listening To Music And Foot Reflexology in Children During Perioperative Period

NCT05655884 | Completed

• 1 other identifier: KAEK117
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The population of the research will be children between the ages of 7 and 12 who underwent day surgery at the Pediatric Surgery Clinic of the Gynecology and Childhood Hospital of Ordu University Training and Research Hospital. The sample of the study will consist of 99 children who have undergone a day surgery operation between the specified dates, who meet the case selection criteria and agree to participate in the study.

Conditions

Perioperative Period

Keywords

Perioperative Period; Pain; Children; Fear

Outcome Measures

Primary Outcomes (4)

• Baxter Nausea Scale- BARF Score

  A score of 0 from the scale indicates that there is no nausea- vomiting, and a score of 10 indicates that there is nausea-vomiting

  Nausea and vomiting change in the perioperative period.

• Eastern Ontario Children's Hospital Pain Scale

  The total score from the scale is evaluated as the lowest 4 points and the highest 13 points. A high total score from the scale indicates that the child has high postoperative pain

  Pain change in the perioperative period.

• Multidimensional Perioperative Anxiety Scale (MCPSPS)

  The scale is a visual analog scale consisting of 5 items and scored between 0-100, prepared for children aged 7-13 who will undergo day surgery. An increase in the score obtained from the scale indicates that the child\'s perioperative anxiety increases.

  Anxiety change in the perioperative period.

• Children's Emotional Indicator Scale (CBRS)

  As the scores obtained from the scale increase, negative emotional indicators increase. The rating is between 5-25 points.

  Emotional change in the perioperative period.

Secondary Outcomes (5)

• Heart rate (HR)

  Heart rate in the perioperative period.

• body temperature

  Body temperature change in the perioperative period.

• oxygen saturation (SpO2)

  SpO2 change in the perioperative period.

• blood pressure

  Blood pressure change in the perioperative period.

• respiratory rate

  respiratory rate change in the perioperative period.

Study Arms (3)

Music Listening Application

EXPERIMENTAL

Children in this group; 15 minutes before going to the surgery, the child's favorite and chosen music piece will be loaded onto the mp3 player and played by the researcher (who has received music therapy training) via the "creatone music pillow" for 15 minutes.

Other: Music Listening Application

Foot Reflexology Practice

EXPERIMENTAL

Children in this group; Before going to the surgery, foot reflexology will be applied by the researcher (who has received reflexology training), only to the left foot, for 10 minutes.

Other: Foot Reflexology Practice:

Control Group

NO INTERVENTION

Children in this group will not be subjected to any non-pharmacological application to reduce nausea, pain and anxiety before and after surgery. They will receive routine perioperative care administered in the clinic.

Interventions

Music Listening Application OTHER

15 minutes before going to the surgery, the child's favorite and chosen music piece will be loaded onto the mp3 player and played by the researcher via the "creatone music pillow" for 15 minutes. After the child returns to the service from the recovery room (the room where the patient is observed in the operating room for a certain period of time until he recovers from the surgery and his general condition is stable), and after he regains consciousness, music will be played by the music group again for 15 minutes.

Music Listening Application

Foot Reflexology Practice: OTHER

Children in this group; Before going to the surgery, foot reflexology will be applied by the researcher, only to the left foot, for 10 minutes. After the child returns to the service from the recovery room (the room where the patient is observed in the operating room for a certain period of time until he recovers from the surgery and his general condition is stable), and after he regains consciousness, foot reflexology will be applied again, only on the left foot, for 10 minutes.

Foot Reflexology Practice

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- The child is between 7-12 years old,
• The child is hospitalized for general anesthesia and surgical operation,
• Parents and children are willing to participate in the research,
• The integrity of the tissue in the foot of the child is intact,
• The child does not have visual, hearing and mental disabilities,
• Parents and children give written and verbal consent,

You may not qualify if:

• The child has a hearing problem,
• The child's hemodynamics is unstable,
• The child has eye surgery, orthopedic surgery, inner ear surgery, adenoidectomy, tonsillectomy,
• The child and the parent do not understand and speak Turkish easily,
• The child is not at the level of mental development to be able to answer the questions asked,
• Development of a high-risk condition in the child in the postoperative period,
• Absence of a primary caregiver,
• The child has a history of analgesic or narcotic substance use within 24 hours before surgery.

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Dilek alemdar

Ordu, 52000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• DİLEK KÜÇÜK ALEMDAR

  Ordu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The research will be structured according to the CONSORT 2010 checklist of information to include when reporting a randomised trial (Schulz et al., 2010) to facilitate clarity, integrity, and transparency. The assignment of children to groups will be made using the "simple randomization method". Children will not be informed about which group they are in (playing music, foot reflexology, control). The data collection tools of the study will be filled by the child, the parent, and an experienced university graduate nurse working in the day surgery clinic independent of the research. The nurse will be informed by the researcher about the scales to be used in the research. The researcher will not be involved in the data collection process, he will only observe the process. In addition, the database of the research will be created by a university graduate statistician working in a statistical center independent of the research, apart from the researcher.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This research was planned as randomized controlled, experimental.

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 19, 2022
• Study Start: December 10, 2021
• Primary Completion: December 1, 2022
• Study Completion: January 15, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)