EpilepsyNCT07827729
Aromatherapy and Music on Sleep and Children With Epilepsy
A study testing Aromatherapy and Music Listening in people with Epilepsy, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study aimed to compare the effects of aromatherapy and music listening with routine care on sleep parameters and cerebral oxygenation in children with epilepsy. Design and methods: This randomized controlled experimental study was conducted between February and December 2023 with children diagnosed with… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Aromatherapy and Music Listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 28 Dec 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Generalized tonic-clonic seizure,
- Children who take at least one antiepileptic drug.
Who cannot join
- Children with hearing problems,
- Children with resistant epilepsy,
- Children diagnosed with sleep disorders,
- Children diagnosed with neurological, psychiatric, or medical disorders other than epilepsy,
- Children with allergies,
- Children with impaired sense of smell,
- Children whose parents did not give consent were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İnönü University Turgut Özal Medical Center
Malatya
About this study
Official title: The Effects of Aromatherapy and Music Listening on Sleep and Cerebral Oxygen Levels in Children With Epilepsy
Purpose: This study aimed to compare the effects of aromatherapy and music listening with routine care on sleep parameters and cerebral oxygenation in children with epilepsy. Design and methods: This randomized controlled experimental study was conducted between February and December 2023 with children diagnosed with epilepsy living in Malatya Province and surrounding regions. The sample consisted of 90 children allocated to aromatherapy (n = 30), music listening (n = 30), and control (n = 30) groups. Children in the intervention groups received aromatherapy or music listening, whereas the control group received routine care only. Data were collected using the Patient Introduction and Follow-up Form, actigraphy, and the Cerebral Oxygen Monitoring Form. One-way ANOVA, Kruskal-Wallis, chi-square, Mann-Whitney U, LSD, and Dunnett's C tests were used for data analysis. Results: Aromatherapy was associated with higher cerebral oxygen levels, longer time spent in bed, longer sleep duration, higher sleep efficiency, and lower sleep onset latency (p < 0.05). Similarly, music listening was associated with higher cerebral oxygen levels, longer sleep duration, and higher sleep efficiency (p < 0.05). Conclusion: Aromatherapy and music listening may improve selected sleep parameters and cerebral oxygenation in children with epilepsy. Practice implications: Aromatherapy and music listening may be considered supportive, non-pharmacological interventions for improving sleep and cerebral oxygenation in pediatric epilepsy care.
- Conditions
- Epilepsy
- Being tested
- Aromatherapy, Music Listening
- Keywords
- Aromatherapy, Music listening, Epilepsy, Sleep, Cerebral oxygen
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
Lavender aromatherapy administered by inhalation using a scented pillow
Music ListeningOther
Child- or parentselected calming music at 45-65 dB
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy Group | Experimental | Before evening sleep, lavender aromatherapy was administered by inhalation for 30 minutes using a scented pillow. NIRS monitoring was initiated concurrently with the 30-minute aromatherapy intervention and continued for a total of 150 minutes. Receives: Other: Aromatherapy |
| Music Listening Group | Experimental | Before evening sleep, music selected by the child or parent was played at 45-65 dB for 30 minutes. NIRS monitoring was initiated concurrently with the 30-minute music-listening intervention and continued for a total of 150 minutes. Receives: Other: Music Listening |
| Control Group | No intervention | Routine care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Spent in Bed
Time spent in bed was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the total time the child spent in bed during the monitored sleep period and was expressed in hours.
Measured: 24-hour actigraphy monitoring period
Awakening Time During Sleep
Awakening time during sleep was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the total duration of wakefulness occurring after sleep onset and before the end of the sleep period and was expressed in
Measured: 24-hour actigraphy monitoring period
Number of Awakenings During Sleep
The number of awakenings during sleep was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the number of episodes scored as wakefulness occurring during the monitored sleep period and was reported as a count.
Measured: 24-hour actigraphy monitoring period
Sleep Duration
Sleep duration was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the total amount of time scored as sleep during the monitored sleep period and was expressed in hours.
Measured: 24-hour actigraphy monitoring period
Sleep Onset Latency
Sleep onset latency was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the time from the beginning of the sleep period to sleep onset and was expressed in minutes.
Measured: 24-hour actigraphy monitoring period
Sleep Efficiency
Sleep efficiency was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the percentage of time spent asleep relative to the total time spent in bed during the monitored sleep period and was expressed as a percentage (%).
Measured: 24-hour actigraphy monitoring period
Regional Cerebral Oxygen Saturation (rSO₂)
Regional cerebral oxygen saturation (rSO₂) was assessed noninvasively using near-infrared spectroscopy (NIRS) with the INVOS 5100C system and compatible INVOS pediatric sensors. rSO₂ values were recorded at 30, 60, 90, 120, and 150 minutes during the monitoring period. The five measurements were averaged to obtain one mean rSO₂ value for each participant. Regional cerebral oxygen saturation was expressed as a percentage (%).
Measured: 150-minute NIRS monitoring period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Feb 2023
- Primary completion15 Aug 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Principal investigator, Mehmet Ali AKDEMİR, Kafkas University
- Investigators
- Emriye Hilal Yayan, Prof. Dr., Study director, Department of Child Health Nursing Faculty of Nursing, Inonu University, 44280 Malatya, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827729
- Sponsor's protocol ID
- PhD.Thesis
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akdemir MA, Yayan EH. The effects of aromatherapy and music listening on sleep and cerebral oxygen levels in children with epilepsy. J Pediatr Nurs. 2026 Oct 31;92:113-123. doi: 10.1016/j.pedn.2026.10.027. Online ahead of print.
PubMed 42965995
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aromatherapy and Music Listening on Sleep and Cerebral Oxygen Levels in Children With Epilepsy
- ClinicalTrials.gov ID
- NCT07827729
- Acronym / sponsor ID
- PhD.Thesis
- Conditions
- Epilepsy
- Keywords
- Aromatherapy, Music listening, Epilepsy, Sleep, Cerebral oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 18 Sep 2026 (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.
Purpose: This study aimed to compare the effects of aromatherapy and music listening with routine care on sleep parameters and cerebral oxygenation in children with epilepsy. Design and methods: This randomized controlled experimental study was conducted between February and December 2023 with children diagnosed with epilepsy living in Malatya Province and surrounding regions. The sample consisted of 90 children allocated to aromatherapy (n = 30), music listening (n = 30), and control (n = 30) groups. Children in the intervention groups received aromatherapy or music listening, whereas the control group received routine care only. Data were collected using the Patient Introduction and Follow-up Form, actigraphy, and the Cerebral Oxygen Monitoring Form. One-way ANOVA, Kruskal-Wallis, chi-square, Mann-Whitney U, LSD, and Dunnett's C tests were used for data analysis. Results: Aromatherapy was associated with higher cerebral oxygen levels, longer time spent in bed, longer sleep duration, higher sleep efficiency, and lower sleep onset latency (p < 0.05). Similarly, music listening was associated with higher cerebral oxygen levels, longer sleep duration, and higher sleep efficiency (p < 0.05). Conclusion: Aromatherapy and music listening may improve selected sleep parameters and cerebral oxygenation in children with epilepsy. Practice implications: Aromatherapy and music listening may be considered supportive, non-pharmacological interventions for improving sleep and cerebral oxygenation in pediatric epilepsy care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy Group | Experimental | Other: AromatherapyBefore evening sleep, lavender aromatherapy was administered by inhalation for 30 minutes using a scented pillow. NIRS monitoring was initiated concurrently with the 30-minute aromatherapy intervention and continued for a total of 150 minutes. |
| Music Listening Group | Experimental | Other: Music ListeningBefore evening sleep, music selected by the child or parent was played at 45-65 dB for 30 minutes. NIRS monitoring was initiated concurrently with the 30-minute music-listening intervention and continued for a total of 150 minutes. |
| Control Group | No intervention | –Routine care only |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Generalized tonic-clonic seizure,
- Children who take at least one antiepileptic drug.
Key exclusion criteria (7 listed)
- Children with hearing problems,
- Children with resistant epilepsy,
- Children diagnosed with sleep disorders,
- Children diagnosed with neurological, psychiatric, or medical disorders other than epilepsy,
- Children with allergies,
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 |
|---|---|---|
| AromatherapyLavender aromatherapy administered by inhalation using a scented pillow | Other | Aromatherapy Group |
| Music ListeningChild- or parentselected calming music at 45-65 dB | Other | Music Listening Group |
Primary outcome
Time Spent in Bed
Time frame: 24-hour actigraphy monitoring period
Time spent in bed was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the total time the child spent in bed during the monitored sleep period and was expressed in hours.
Awakening Time During Sleep
Time frame: 24-hour actigraphy monitoring period
Awakening time during sleep was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the total duration of wakefulness occurring after sleep onset and before the end of the sleep period and was expressed in
Number of Awakenings During Sleep
Time frame: 24-hour actigraphy monitoring period
The number of awakenings during sleep was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the number of episodes scored as wakefulness occurring during the monitored sleep period and was reported as a count.
Sleep Duration
Time frame: 24-hour actigraphy monitoring period
Sleep duration was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the total amount of time scored as sleep during the monitored sleep period and was expressed in hours.
Sleep Onset Latency
Time frame: 24-hour actigraphy monitoring period
Sleep onset latency was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the time from the beginning of the sleep period to sleep onset and was expressed in minutes.
Sleep Efficiency
Time frame: 24-hour actigraphy monitoring period
Sleep efficiency was objectively assessed using the Actiwatch 2 actigraphy device and Actiware 6 software. It represents the percentage of time spent asleep relative to the total time spent in bed during the monitored sleep period and was expressed as a percentage (%).
Regional Cerebral Oxygen Saturation (rSO₂)
Time frame: 150-minute NIRS monitoring period
Regional cerebral oxygen saturation (rSO₂) was assessed noninvasively using near-infrared spectroscopy (NIRS) with the INVOS 5100C system and compatible INVOS pediatric sensors. rSO₂ values were recorded at 30, 60, 90, 120, and 150 minutes during the monitoring period. The five measurements were averaged to obtain one mean rSO₂ value for each participant. Regional cerebral oxygen saturation was expressed as a percentage (%).
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 18 Sep 2026.
- Derived from this study: PubMed 42965995Akdemir MA, Yayan EH. The effects of aromatherapy and music listening on sleep and cerebral oxygen levels in children with epilepsy. J Pediatr Nurs. 2026 Oct 31;92:113-123. doi: 10.1016/j.pedn.2026.10.027. Online ahead of print.
- 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.
Emriye Hilal Yayan, Prof. Dr. study director
Department of Child Health Nursing Faculty of Nursing, Inonu University, 44280 Malatya, Türkiye
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 Listening in people with Epilepsy, run by Kafkas 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 2 inclusion and 7 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 18 Sep 2026. 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?
Time Spent in Bed (time frame: 24-hour actigraphy monitoring period). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07827729, which also lists 1 linked publication.
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 18 Sep 2026.