Aromatherapy and Music on Sleep and Children With Epilepsy

NCT07827729 | Completed

• 1 other identifier: PhD.Thesis
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Aromatherapy; Music listening; Epilepsy; Sleep; Cerebral oxygen

Outcome Measures

Primary Outcomes (7)

• 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.

  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

  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.

  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.

  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.

  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 (%).

  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 (%).

  150-minute NIRS monitoring period

Study Arms (3)

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.

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.

Other: Music Listening

Control Group

NO INTERVENTION

Routine care only

Interventions

Aromatherapy OTHER

Lavender aromatherapy administered by inhalation using a scented pillow

Aromatherapy Group

Music Listening OTHER

Child- or parentselected calming music at 45-65 dB

Music Listening Group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafkas University: lead
• Inonu University: collaborator

Study Sites (1)

İnönü University Turgut Özal Medical Center

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Emriye Hilal Yayan, Prof. Dr.

  Department of Child Health Nursing Faculty of Nursing, Inonu University, 44280 Malatya, Türkiye

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 18, 2026
• Study Start: February 1, 2023
• Primary Completion: August 15, 2023
• Study Completion: December 28, 2023
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)