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

NCT ID: NCT05655884

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-10
• Study Completion Date: 2023-01-15

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.

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).

Conditions

Perioperative Period

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Music Listening Application

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Foot Reflexology Practice:

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ordu University

OTHER

Sponsor Role: lead

Responsible Party

Dilek Kucuk Alemdar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

DİLEK KÜÇÜK ALEMDAR

Role: STUDY_DIRECTOR

Ordu University

Locations

Dilek alemdar

Ordu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KAEK117

Identifier Type: -

Identifier Source: org_study_id