Perioperative PeriodNCT05655884
The Effect of Listening To Music And Foot Reflexology in Children During Perioperative Period
A study testing Music Listening Application and Foot Reflexology Practice: in people with Perioperative Period, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Perioperative Period
- What is being tested?
- Music Listening Application and Foot Reflexology Practice:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2021to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Music Listening Application, Foot Reflexology Practice:
- Keywords
- Perioperative Period, Pain, Children, Fear
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Listening ApplicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Emotional change in the perioperative period.
Secondary outcomes (5)
Heart rate (HR)
It was created to monitor the heart rate (HR) of children in the perioperative period.
Measured: Heart rate in the perioperative period.
body temperature
body temperature of children in the perioperative period.
Measured: Body temperature change in the perioperative period.
oxygen saturation (SpO2)
oxygen saturation (SpO2) of children in the perioperative period.
Measured: SpO2 change in the perioperative period.
blood pressure
blood pressure of children in the perioperative period.
Measured: Blood pressure change in the perioperative period.
respiratory rate
respiratory rate of children in the perioperative period.
Measured: respiratory rate change in the perioperative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start10 Dec 2021
- Primary completion1 Dec 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative PeriodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research was planned as randomized controlled, experimental.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Kucuk Alemdar, Ordu University
- Investigators
- DİLEK KÜÇÜK ALEMDAR, Study director, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655884
- Sponsor's protocol ID
- KAEK117
- Status last verified
- May 2023
- First submitted
- 28 Nov 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening To Music And Foot Reflexology on Nausea, Pain And Anxiety in Children During Perioperative Period
- ClinicalTrials.gov ID
- NCT05655884
- Acronym / sponsor ID
- KAEK117
- Conditions
- Perioperative Period
- Keywords
- Perioperative Period, Pain, Children, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This research was planned as randomized controlled, experimental.
| Arm | Type | Receives |
|---|---|---|
| Music Listening Application | Experimental | Other: Music Listening ApplicationChildren 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. |
| Foot Reflexology Practice | Experimental | Other: 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. |
| 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- - 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,
Key exclusion criteria (8 listed)
- The child has a hearing problem,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Listening Application15 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. | Other | Music Listening Application |
| 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. | Other | Foot Reflexology Practice |
Primary outcome
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
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
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.
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.
5 secondary outcomes
Heart rate (HR)
Time frame: Heart rate in the perioperative period.
body temperature
Time frame: Body temperature change in the perioperative period.
oxygen saturation (SpO2)
Time frame: SpO2 change in the perioperative period.
blood pressure
Time frame: Blood pressure change in the perioperative period.
respiratory rate
Time frame: respiratory rate change in the perioperative period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DİLEK KÜÇÜK ALEMDAR study director
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Listening Application and Foot Reflexology Practice: in people with Perioperative Period, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baxter Nausea Scale- BARF Score (time frame: Nausea and vomiting change in the perioperative period.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.