Pain2024-KAEK-11NCT07040410
Aromatherapy and Music on Pain, Vital Signs and Parental Satisfaction in Children Undergoing Peritoneal Dialysis
A study testing Aromatherapy and Music Therapy in people with Pain and Vital Signs Monitoring, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
This study is an experimental randomized controlled study conducted to compare the effect of two different nonpharmacological treatment methods (aromatherapy and music therapy) on pain, vital signs and parental satisfaction to alleviate or eliminate pain during excretion and filling in children undergoing peritoneal… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pain, Vital Signs Monitoring, Parental Satisfaction
- What is being tested?
- Aromatherapy and Music Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2025to 25 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children will be included between the ages of 3 and 18 who receive instrumental peritoneal dialysis or continuous outpatient peritoneal dialysis treatment.
- Children who have a sufficient cognitive level (3-18 years) to determine pain scores,
- Children who have a healthy hearing and vision system,
- Children who did not take painkillers, opioids or sedatives 6 hours before the study,
- Children who have absence of severe pain in another part of the body,
- Children who have absence of a history of allergies,
- Children and parents who can speak and understand Turkish.
Who cannot join
- Decline to participate in the study,
- Peritonitis diagnosis,
- Pain due to catheter immobilization,
- Receiving the first session of peritoneal dialysis treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Burcu Aykanat Girgin, PhD, RN, Associate Professor contact
Turkey (Türkiye)1 site
İstanbul Sağlık Bilimleri University
Istanbul, Üsküdar, 34899
About this study
Official title: The Effect of Aromatherapy and Music on Pain, Vital Signs and Parental Satisfaction in Children Undergoing Peritoneal Dialysis Treatment: A Randomized Controlled Study
This study is an experimental randomized controlled study conducted to compare the effect of two different nonpharmacological treatment methods (aromatherapy and music therapy) on pain, vital signs and parental satisfaction to alleviate or eliminate pain during excretion and filling in children undergoing peritoneal dialysis treatment. The study population consists of pediatric patients aged 3 to 18 years undergoing peritoneal dialysis treatment at Basaksehir Cam and Sakura City Hospital between June 2025- 2026. According to literature, for experimental studies and parametric measurements, at least 30 participants should be included in both experimental and control groups. Therefore, this crossover randomized design will include 45 children per group: control, aromatherapy, and music therapy. Children included in the sample will be assigned to groups based on a crossover randomized design. This method is suitable for studies with a small sample size. Since three different interventions will be applied once per session over three sessions, to avoid bias, the order of interventions will be randomized and labeled as A, B, and C. The researcher will write the names of the interventions on three separate papers, draw them one by one, and assign them accordingly: Method A: Aromatherapy, Method B: Music Therapy, Method C: Control. Then, the six possible sequences (ABC, ACB, BAC, BCA, CAB, CBA) will be written on six papers and drawn randomly to determine the intervention order for each participant.
Read the detailed description
The study is a randomized controlled, non-blinded, experimental trial. The study population consists of pediatric patients aged 3 to 18 years undergoing peritoneal dialysis treatment at Basaksehir Cam and Sakura City Hospital between June 2025-2026. According to literature, for experimental studies and parametric measurements, at least 30 participants should be included in both experimental and control groups. Therefore, this crossover randomized design will include 45 children per group: control, aromatherapy, and music therapy. Children included in the sample will be assigned to groups based on a crossover randomized design. In order to prevent bias and increase the validity of the data, the pain scores of the children before and after the procedure were assessed by three different groups as children participating in the study (n:45), their parents as the people who know the children best (n:45), and a researcher specialized in pediatric nursing (n:1), and the inter-observer agreement was examined.
The data collection phase of the research is planned to be completed between June 2025-2026.In this experimental study, the children and their parents who came to the nephrology clinics were evaluated in terms of the inclusion criteria and the children and parents who did not meet the criteria were excluded from the study. The children and parents complying with the inclusion criteria were informed about the study and their written and verbal consents were received. Pre-application will be made before starting the data collection process.
Pilot Study Phase: Children and parents meeting the inclusion criteria will be informed about the study and their verbal and written consent will be obtained. A pilot will be conducted with five children. Based on the results, data collection tools will be revised if necessary.
Pre-Implementation Phase: Children and parents included in the sample will be informed about the study. Written and verbal consent will be obtained. The "Descriptive Information Form" and "Vital Signs Evaluation Form" will be completed by the researcher before the peritoneal dialysis session begins. To avoid causing additional pain, no invasive procedure will be performed within 30 minutes prior to the PD session. Group assignments will be determined through randomization. The PD session will be performed in accordance with physician recommendations.
Implementation Phase: To eliminate variation from different nursing techniques, data collection and application of non-pharmacological interventions will be carried out solely by the researcher. Each child will participate in the control, aromatherapy, and music therapy groups in a randomized order (n = 45 per group).
Control Group: Peritoneal dialysis treatment will be started with discharge first, and then the amount of dialysate fluid determined by the physician's request will be filled. In the clinical routine, nonpharmacological pain treatment method is not applied during excretion and filling. Nonpharmacological pain treatment method will not be applied to the control group. The "Wong-Baker Facial Expressions Rating Scale" and "Life Signs Evaluation Form" will be filled in by the researcher at the 0th and 1st minutes of the first discharge and at the 0th and 1st minutes of the first filling.
Aromatherapy Group: Fifteen minutes before the PD session and during the first outflow and inflow phases, aromatherapy will be administered via inhalation. Five drops of 100% pure organic lavender oil will be added to drinking water in a diffuser visible to the child and parent. The diffuser will be plugged in at the bedside, and participants will be warned not to touch the device. Pain and vital signs will be assessed as in the control group.
Music Therapy Group: Fifteen minutes before the PD session and during the first outflow and inflow phases, music chosen by the child or parent will be played. Pain and vital signs will be assessed as in the control group.
Post-Implementation Phase: After completing the assigned intervention and while the dialysate dwells in the peritoneum, no additional non-pharmacological methods will be applied. During this phase, the Parental Satisfaction Questionnaire will be completed by the researcher. Data collection will conclude once the required sample size is reached. The study followed the CONSORT guideline for reporting randomized controlled trials.
- Conditions
- Pain, Vital Signs Monitoring, Parental Satisfaction
- Being tested
- Aromatherapy, Music Therapy, Control
- Keywords
- peritoneal dialysis treatment, pain management, pain in children, non-pharmacological method, satisfaction
- Medical subject headings
- Pain, Agnosia, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyProcedure or surgery
Fifteen minutes before the PD session and during the first outflow and inflow phases, aromatherapy will be administered via inhalation. Five drops of 100% pure organic lavender oil
Music TherapyProcedure or surgery
Fifteen minutes before the PD session and during the first outflow and inflow phases, music chosen by the child or parent will be played. Pain and vital signs will be assessed as in the control group.
ControlProcedure or surgery
Peritoneal dialysis treatment will be started with discharge first, and then the amount of dialysate fluid determined by the physician's request will be filled. In the clinical routine, nonpharmacological pain treatment method is not applied during excretion and filling. Nonpharmacological pain treatment method will not be applied to the control group. The "Wong-Baker Facial Expressions Rating Scale" and "Life Signs Evaluation Form" will be filled in by the researcher at the 0th and 1st minutes of the first discharge and at the 0th and 1st minutes of the first filling.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy | Experimental | Fifteen minutes before the PD session and during the first outflow and inflow phases, aromatherapy will be administered via inhalation. Five drops of 100% pure organic lavender oil will be added to drinking water in a diffuser visible to the child and parent. The diffuser will be plugged in at the bedside, and participants will be warned not to touch the device. Pain and vital signs will be assessed as in the control group. Receives: Procedure: Aromatherapy |
| Music Therapy | Experimental | Fifteen minutes before the PD session and during the first outflow and inflow phases, music chosen by the child or parent will be played. Pain and vital signs will be assessed as in the control group. Receives: Procedure: Music Therapy |
| Control | Experimental | Peritoneal dialysis treatment will be started with discharge first, and then the amount of dialysate fluid determined by the physician's request will be filled. In the clinical routine, nonpharmacological pain treatment method is not applied during excretion and filling. Nonpharmacological pain treatment method will not be applied to the control group. The "Wong-Baker Facial Expressions Rating Scale" and "Life Signs Evaluation Form" will be filled in by the researcher at the 0th and 1st minutes of the first discharge and at the 0th and 1st minutes of the first filling. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
The children and the parents were informed about the Wong Baker Faces Pain Rating Scale and they were asked to mark the children's pain levels on the scale. In addition, the pain levels of the children before and after the procedure were determined by the researcher who is a specialist in pediatric nursing by using the same scales. The scale will be applied at 0 and 1 minute of the first outflow and inflow phases by the researcher.
Measured: 12 months
Secondary outcomes (3)
Heart Rate Monitoring
Developed by the researchers, this form records heart rate using a Philips monitor before, during (0 and 1 minute), and after the first outflow and inflow.
Measured: 12 months
Oxygen Saturation Monitoring
Developed by the researchers, this form records oxygen saturation using a Philips monitor before, during (0 and 1 minute), and after the first outflow and inflow.
Measured: 12 months
Parental Satisfaction
This researcher-developed questionnaire evaluates parent satisfaction with the non-pharmacological pain management method applied during the first inflow and outflow of PD. It consists of five yes/no questions. Each "yes" is scored as 1 and each "no" as 0, with total scores ranging from 0 to 10. Higher scores indicate greater satisfaction. The form will be completed after the first PD session
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start25 Jun 2025 (estimated)
- Primary completion25 Jun 2026 (estimated)
- Study completion25 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is designed as an interventional, cross-over, randomized-controlled design.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Aktaş, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040410
- Sponsor's protocol ID
- KAEK-11/30.04.2025.142
- Other IDs
- KAEK-11/30.04.2025.142
- Acronym
- 2024-KAEK-11
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data set will be shared online with other researchers during the data collection phase and while the data is being analyzed.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy and Music on Pain, Vital Signs and Parental Satisfaction in Children Undergoing Peritoneal Dialysis Treatment: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07040410
- Acronym / sponsor ID
- 2024-KAEK-11 / KAEK-11/30.04.2025.142
- Conditions
- Pain, Vital Signs Monitoring, Parental Satisfaction
- Keywords
- peritoneal dialysis treatment, pain management, pain in children, non-pharmacological method, satisfaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 25 Jun 2026 (estimated)
- First posted
- 27 Jun 2025 (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.
This study is an experimental randomized controlled study conducted to compare the effect of two different nonpharmacological treatment methods (aromatherapy and music therapy) on pain, vital signs and parental satisfaction to alleviate or eliminate pain during excretion and filling in children undergoing peritoneal dialysis treatment. The study population consists of pediatric patients aged 3 to 18 years undergoing peritoneal dialysis treatment at Basaksehir Cam and Sakura City Hospital between June 2025- 2026. According to literature, for experimental studies and parametric measurements, at least 30 participants should be included in both experimental and control groups. Therefore, this crossover randomized design will include 45 children per group: control, aromatherapy, and music therapy. Children included in the sample will be assigned to groups based on a crossover randomized design. This method is suitable for studies with a small sample size. Since three different interventions will be applied once per session over three sessions, to avoid bias, the order of interventions will be randomized and labeled as A, B, and C. The researcher will write the names of the interventions on three separate papers, draw them one by one, and assign them accordingly: Method A: Aromatherapy, Method B: Music Therapy, Method C: Control. Then, the six possible sequences (ABC, ACB, BAC, BCA, CAB, CBA) will be written on six papers and drawn randomly to determine the intervention order for each participant.
Detailed description
The study is a randomized controlled, non-blinded, experimental trial. The study population consists of pediatric patients aged 3 to 18 years undergoing peritoneal dialysis treatment at Basaksehir Cam and Sakura City Hospital between June 2025-2026. According to literature, for experimental studies and parametric measurements, at least 30 participants should be included in both experimental and control groups. Therefore, this crossover randomized design will include 45 children per group: control, aromatherapy, and music therapy. Children included in the sample will be assigned to groups based on a crossover randomized design. In order to prevent bias and increase the validity of the data, the pain scores of the children before and after the procedure were assessed by three different groups as children participating in the study (n:45), their parents as the people who know the children best (n:45), and a researcher specialized in pediatric nursing (n:1), and the inter-observer agreement was examined.
The data collection phase of the research is planned to be completed between June 2025-2026.In this experimental study, the children and their parents who came to the nephrology clinics were evaluated in terms of the inclusion criteria and the children and parents who did not meet the criteria were excluded from the study. The children and parents complying with the inclusion criteria were informed about the study and their written and verbal consents were received. Pre-application will be made before starting the data collection process.
Pilot Study Phase: Children and parents meeting the inclusion criteria will be informed about the study and their verbal and written consent will be obtained. A pilot will be conducted with five children. Based on the results, data collection tools will be revised if necessary.
Pre-Implementation Phase: Children and parents included in the sample will be informed about the study. Written and verbal consent will be obtained. The "Descriptive Information Form" and "Vital Signs Evaluation Form" will be completed by the researcher before the peritoneal dialysis session begins. To avoid causing additional pain, no invasive procedure will be performed within 30 minutes prior to the PD session. Group assignments will be determined through randomization. The PD session will be performed in accordance with physician recommendations.
Implementation Phase: To eliminate variation from different nursing techniques, data collection and application of non-pharmacological interventions will be carried out solely by the researcher. Each child will participate in the control, aromatherapy, and music therapy groups in a randomized order (n = 45 per group).
Control Group: Peritoneal dialysis treatment will be started with discharge first, and then the amount of dialysate fluid determined by the physician's request will be filled. In the clinical routine, nonpharmacological pain treatment method is not applied during excretion and filling. Nonpharmacological pain treatment method will not be applied to the control group. The "Wong-Baker Facial Expressions Rating Scale" and "Life Signs Evaluation Form" will be filled in by the researcher at the 0th and 1st minutes of the first discharge and at the 0th and 1st minutes of the first filling.
Aromatherapy Group: Fifteen minutes before the PD session and during the first outflow and inflow phases, aromatherapy will be administered via inhalation. Five drops of 100% pure organic lavender oil will be added to drinking water in a diffuser visible to the child and parent. The diffuser will be plugged in at the bedside, and participants will be warned not to touch the device. Pain and vital signs will be assessed as in the control group.
Music Therapy Group: Fifteen minutes before the PD session and during the first outflow and inflow phases, music chosen by the child or parent will be played. Pain and vital signs will be assessed as in the control group.
Post-Implementation Phase: After completing the assigned intervention and while the dialysate dwells in the peritoneum, no additional non-pharmacological methods will be applied. During this phase, the Parental Satisfaction Questionnaire will be completed by the researcher. Data collection will conclude once the required sample size is reached. The study followed the CONSORT guideline for reporting randomized controlled trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is designed as an interventional, cross-over, randomized-controlled design.
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy | Experimental | Procedure: AromatherapyFifteen minutes before the PD session and during the first outflow and inflow phases, aromatherapy will be administered via inhalation. Five drops of 100% pure organic lavender oil will be added to drinking water in a diffuser visible to the child and parent. The diffuser will be plugged in at the bedside, and participants will be warned not to touch the device. Pain and vital signs will be assessed as in the control group. |
| Music Therapy | Experimental | Procedure: Music TherapyFifteen minutes before the PD session and during the first outflow and inflow phases, music chosen by the child or parent will be played. Pain and vital signs will be assessed as in the control group. |
| Control | Experimental | Procedure: ControlPeritoneal dialysis treatment will be started with discharge first, and then the amount of dialysate fluid determined by the physician's request will be filled. In the clinical routine, nonpharmacological pain treatment method is not applied during excretion and filling. Nonpharmacological pain treatment method will not be applied to the control group. The "Wong-Baker Facial Expressions Rating Scale" and "Life Signs Evaluation Form" will be filled in by the researcher at the 0th and 1st minutes of the first discharge and at the 0th and 1st minutes of the first filling. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children will be included between the ages of 3 and 18 who receive instrumental peritoneal dialysis or continuous outpatient peritoneal dialysis treatment.
- Children who have a sufficient cognitive level (3-18 years) to determine pain scores,
- Children who have a healthy hearing and vision system,
- Children who did not take painkillers, opioids or sedatives 6 hours before the study,
- Children who have absence of severe pain in another part of the body,
Key exclusion criteria (4 listed)
- Decline to participate in the study,
- Peritonitis diagnosis,
- Pain due to catheter immobilization,
- Receiving the first session of peritoneal dialysis treatment
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 |
|---|---|---|
| AromatherapyFifteen minutes before the PD session and during the first outflow and inflow phases, aromatherapy will be administered via inhalation. Five drops of 100% pure organic lavender oil | Procedure or surgery | Aromatherapy |
| Music TherapyFifteen minutes before the PD session and during the first outflow and inflow phases, music chosen by the child or parent will be played. Pain and vital signs will be assessed as in the control group. | Procedure or surgery | Music Therapy |
| ControlPeritoneal dialysis treatment will be started with discharge first, and then the amount of dialysate fluid determined by the physician's request will be filled. In the clinical routine, nonpharmacological pain treatment method is not applied during excretion and filling. Nonpharmacological pain treatment method will not be applied to the control group. The "Wong-Baker Facial Expressions Rating Scale" and "Life Signs Evaluation Form" will be filled in by the researcher at the 0th and 1st minutes of the first discharge and at the 0th and 1st minutes of the first filling. | Procedure or surgery | Control |
Primary outcome
Pain severity
Time frame: 12 months
The children and the parents were informed about the Wong Baker Faces Pain Rating Scale and they were asked to mark the children's pain levels on the scale. In addition, the pain levels of the children before and after the procedure were determined by the researcher who is a specialist in pediatric nursing by using the same scales. The scale will be applied at 0 and 1 minute of the first outflow and inflow phases by the researcher.
3 secondary outcomes
Heart Rate Monitoring
Time frame: 12 months
Oxygen Saturation Monitoring
Time frame: 12 months
Parental Satisfaction
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: Yes. The data set will be shared online with other researchers during the data collection phase and while the data is being analyzed.
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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.
Burcu Aykanat Girgin, PhD, RN, Associate Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy and Music Therapy in people with Pain and Vital Signs Monitoring, run by Istanbul Saglik Bilimleri 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eda Aktaş, PhD, RN, Associate Professor (+90 530 558 90 36, eda.aktas@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity (time frame: 12 months). 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 27 Jun 2025.