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Completed

NCT Number: NCT05655884

The Effect of Listening To Music And Foot Reflexology 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.

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Key information

Conditions

Perioperative Period Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dilek alemdar

Ordu, 52000, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. body temperature

    Time frame: Body temperature change in the perioperative period.

    body temperature of children in the perioperative period.

  3. oxygen saturation (SpO2)

    Time frame: SpO2 change in the perioperative period.

    oxygen saturation (SpO2) of children in the perioperative period.

  4. blood pressure

    Time frame: Blood pressure change in the perioperative period.

    blood pressure of children in the perioperative period.

  5. respiratory rate

    Time frame: respiratory rate change in the perioperative period.

    respiratory rate of children in the perioperative period.

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 19, 2022
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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