Clinical trial NCT05655884: The Effect of Listening To Music And Foot Reflexology in Children During Perioperative Period
Official title: The Effect of Listening To Music And Foot Reflexology on Nausea, Pain And Anxiety in Children During Perioperative Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Period
Keywords: Perioperative Period
Pain
Children
Fear
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 99
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research was planned as randomized controlled, experimental.
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Baxter Nausea Scale- BARF Score
timeFrame: Nausea and vomiting change in the perioperative period.
measure: Eastern Ontario Children's Hospital Pain Scale
timeFrame: Pain change in the perioperative period.
measure: Multidimensional Perioperative Anxiety Scale (MCPSPS)
timeFrame: Anxiety change in the perioperative period.
measure: Children's Emotional Indicator Scale (CBRS)
timeFrame: Emotional change in the perioperative period.
Secondary outcomes:
measure: Heart rate (HR)
timeFrame: Heart rate in the perioperative period.
measure: body temperature
timeFrame: Body temperature change in the perioperative period.
measure: oxygen saturation (SpO2)
timeFrame: SpO2 change in the perioperative period.
measure: blood pressure
timeFrame: Blood pressure change in the perioperative period.
measure: respiratory rate
timeFrame: respiratory rate change in the perioperative period.
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Dilek alemdar
Study officials:
affiliation: T.C. ORDU ÜNİVERSİTESİ
name: DİLEK KÜÇÜK ALEMDAR
role: STUDY_DIRECTOR
References: