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Completed

NCT Number: NCT07827729

Aromatherapy and Music on Sleep and 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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İnönü University Turgut Özal Medical Center

Malatya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Generalized tonic-clonic seizure,
  • Children who take at least one antiepileptic drug.

Exclusion criteria

  • 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.

Treatment and study plan

Aromatherapy

Other

Lavender aromatherapy administered by inhalation using a scented pillow

Music listening

Other

Child- or parentselected calming music at 45-65 dB

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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 (%).

  7. 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 (%).

Sponsors and collaborators

Lead sponsor

Kafkas University

Other

Collaborators

  • Inonu University

Registry information

Official study title

The Effects of Aromatherapy and Music Listening on Sleep and Cerebral Oxygen Levels in Children With Epilepsy

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

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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