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

May 24, 2023 updated by: Dilek Kucuk Alemdar, T.C. ORDU ÜNİVERSİTESİ

The Effect of Listening To Music And Foot Reflexology on Nausea, Pain And Anxiety in Children During Perioperative Period

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

First of all, the hospitalized children and their parents will be informed about the study. Verbal and written consent will be obtained from the child and his/her parents who agreed to participate in the study before starting the study. "Child and Parent Descriptive Information Form, Baxter Nausea Scale-BARF, Multidimensional Perioperative Anxiety Scale in Children and Children's Emotional Indicator Scale will be administered to all children in the experimental and control groups 30 minutes before the operation (1st measurement). Before going to the operation, the music listening group will listen to music with a music pillow for 15 minutes, foot reflexology will be applied for 10 minutes to the foot reflexology group, and no application will be made to the control group. 10 minutes after the application, Baxter Nausea Scale-BARF, Multidimensional Perioperative Anxiety Scale in Children and Children's Emotional Indicator Scale will be administered again to all three groups (experimental and control) (2nd measurement). When the child comes to the service from the recovery unit after the surgery and after the necessary medical intervention (60th minute postoperatively), all scales will be applied (3rd measurement) and then the music listening group will be listened to with a music pillow for 15 minutes, reflexology will be applied to the foot reflexology group for 10 minutes, and the control group will be no application will be made and after 10 minutes all the scales will be re-administered to the experimental and control groups (4th measurement). Finally, 30 minutes before the child is discharged. First, all scales will be applied to the experimental and control groups again and an evaluation will be made with these results (5th measurement).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ordu, Turkey, 52000
        • Dilek alemdar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • - 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,

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
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.
Experimental: Music Listening Application
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
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.
Experimental: Foot Reflexology Practice
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:
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baxter Nausea Scale- BARF Score
Time Frame: Nausea and vomiting change in the perioperative period.
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
Time Frame: Pain change in the perioperative period.
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)
Time Frame: Anxiety change in the perioperative period.

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)
Time Frame: Emotional change in the perioperative period.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart rate (HR)
Time Frame: Heart rate in the perioperative period.
It was created to monitor the heart rate (HR) of children in the perioperative period.
Heart rate in the perioperative period.
body temperature
Time Frame: Body temperature change in the perioperative period.
body temperature of children in the perioperative period.
Body temperature change in the perioperative period.
oxygen saturation (SpO2)
Time Frame: SpO2 change in the perioperative period.
oxygen saturation (SpO2) of children in the perioperative period.
SpO2 change in the perioperative period.
blood pressure
Time Frame: Blood pressure change in the perioperative period.
blood pressure of children in the perioperative period.
Blood pressure change in the perioperative period.
respiratory rate
Time Frame: respiratory rate change in the perioperative period.
respiratory rate of children in the perioperative period.
respiratory rate change in the perioperative period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
T.C. ORDU ÜNİVERSİTESİ

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: DİLEK KÜÇÜK ALEMDAR, T.C. ORDU ÜNİVERSİTESİ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KAEK117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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