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Sleep problems may affect individuals' daily functioning, emotional well-being, cognitive performance, and quality of life. Non-pharmacological approaches, including sleep hygiene education, sensory-based strategies, and behavioral relaxation techniques, may help individuals develop healthier sleep routines. However, studies directly comparing sensory-based and behavioral approaches are limited.
The aim of this randomized controlled study is to compare the effects of sensory-based and behavioral sleep interventions in adults experiencing poor sleep quality. Participants are randomly assigned to one of three groups: a sleep hygiene education group, a sensory-based intervention group, or a behavioral intervention group. All participants receive a standardized six-week sleep hygiene education program. In addition, the sensory-based intervention group uses aromatherapy and pink noise, while the behavioral intervention group practices progressive muscle relaxation and diaphragmatic breathing exercises.
Participants are assessed before and after the six-week intervention period. The study examines changes in sleep quality and sleep-related behaviors, as well as anxiety, quality of life, activity-role balance, sensory processing characteristics, autonomic nervous system activity, and sleep parameters. The study is expected to provide information about the potential contribution of sensory-based and behavioral strategies to the management of sleep problems.
This study is a three-arm, randomized controlled, single-blind trial designed to compare sensory-based and behavioral sleep interventions in individuals with poor sleep quality.
Eligible participants are randomly assigned to one of three parallel groups: a control group receiving standardized sleep hygiene education, a sensory-based intervention group, or a behavioral intervention group. Randomization is performed using a computer-generated random-number sequence. Attention is given to maintaining a balanced distribution of age and sex across the study groups. Because the researcher responsible for delivering the interventions is aware of group allocation, participant and intervention-provider blinding is not feasible. However, study data are coded and analyzed by an independent statistician who is blinded to group allocation.
All participants receive a standardized sleep hygiene education program lasting six weeks. The education addresses behavioral and environmental factors associated with sleep, including maintaining regular sleep and wake times, limiting caffeine, nicotine, and alcohol before bedtime, reducing exposure to stimulating activities, and arranging the sleep environment in terms of light, noise, and room temperature. Educational content is delivered through an online social media platform and supported by weekly telephone follow-up.
Participants allocated to the sensory-based intervention group receive the sleep hygiene education program together with sensory regulation strategies. These strategies include the inhalation of lavender and orange essential oils before sleep and exposure to pink noise during the transition to sleep. Participants are instructed in the standardized home-based use of these strategies, and adherence is monitored through weekly telephone calls.
Participants allocated to the behavioral intervention group receive the sleep hygiene education program together with progressive muscle relaxation and diaphragmatic breathing exercises. Audio recordings and written instructions are provided to support the standardized home-based practice of these techniques. Adherence is also monitored through weekly telephone calls.
The control group receives the standardized sleep hygiene education program without the additional sensory-based or behavioral components.
Assessments are conducted before the intervention and after completion of the six-week intervention period under standardized conditions. The primary focus of the study is the comparison of changes in sleep quality among the three groups. Additional assessments examine sleep hygiene, anxiety symptoms, quality of life, activity-role balance, sensory processing patterns, autonomic nervous system activity, and wearable-device-based sleep parameters.
Autonomic nervous system activity is assessed using heart rate variability recordings. Objective sleep parameters are monitored using a wearable activity-tracking device throughout the intervention period. Participants also maintain a daily sleep diary to record sleep-related routines and behaviors.
Intervention materials, application instructions, follow-up procedures, and assessment conditions are standardized across participants to support intervention fidelity and comparability. Participants are asked not to begin a new sleep-related treatment during the study period.
Study data are recorded using standardized data collection forms and participant identification codes. Data entries are reviewed for completeness, consistency, and values outside predefined ranges before statistical analysis. Where discrepancies are identified, entries are checked against the original assessment forms, sleep diaries, and device records. Access to identifiable information is restricted to authorized study personnel, and the analysis dataset is prepared in coded form. Missing data and protocol deviations are documented and addressed in accordance with the prespecified statistical analysis procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Hygiene Education | Active Comparator | Participants in this group receive a standardized six-week sleep hygiene education program. The program includes recommendations on maintaining regular sleep and wake times, limiting caffeine, nicotine, and alcohol before bedtime, reducing stimulating activities and screen exposure, and arranging the sleep environment in terms of light, noise, and room temperature. Participants receive weekly follow-up telephone calls to support adherence to the program. |
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| Sleep Hygiene Education Plus Sensory-Based Intervention | Experimental | Participants in this group receive the standardized six-week sleep hygiene education program together with a sensory-based intervention. The sensory intervention includes inhalation of lavender and orange essential oils before bedtime and exposure to pink noise during the transition to sleep. Participants receive standardized instructions for home-based application, and adherence is monitored through weekly follow-up telephone calls. |
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| Sleep Hygiene Education Plus Behavioral Intervention | Experimental | Participants in this group receive the standardized six-week sleep hygiene education program together with a behavioral intervention. The behavioral intervention includes progressive muscle relaxation and diaphragmatic breathing exercises performed before bedtime. Participants receive written instructions and audio recordings to support standardized home-based practice, and adherence is monitored through weekly follow-up telephone calls. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Hygiene Education | Behavioral | Participants receive a standardized six-week sleep hygiene education program. The program covers sleep physiology and the use of a sleep diary, the principles and importance of sleep hygiene, behavioral and cognitive strategies that may support sleep, characteristics of an appropriate sleep environment, evaluation of current sleep habits, factors affecting sleep quality, and reinforcement of acquired sleep-related behaviors. The educational content is delivered remotely, and adherence is supported through weekly telephone follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pittsburgh Sleep Quality Index Global Score | Sleep quality is assessed using the Pittsburgh Sleep Quality Index. The scale evaluates subjective sleep quality during the previous month and provides a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. The outcome is the change in the global score from baseline to the post-intervention assessment. | Baseline and immediately after completion of the 6-week intervention |
| Change in Sleep Hygiene Index Total Score | Sleep hygiene is assessed using the Sleep Hygiene Index, which evaluates the frequency of behaviors and environmental practices that may negatively affect sleep. Higher total scores indicate poorer sleep hygiene. The outcome is the change in the total score from baseline to the post-intervention assessment. | Baseline and immediately after completion of the 6-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Beck Anxiety Inventory Total Score | Anxiety symptoms are assessed using the 21-item Beck Anxiety Inventory. Each item is scored from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate greater anxiety symptom severity. The outcome is the change in the total score from baseline to the post-intervention assessment. | Baseline and immediately after completion of the 6-week intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zeynep Çorakcı Yazıcıoğlu | Contact | +905376699979 | zcorakci@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlas University | Recruiting | Istanbul | Istanbul | 34672 | Turkey (Türkiye) |
Individual participant data will not be made publicly available because the informed consent obtained from participants does not include permission for public or unrestricted sharing of individual-level data. In addition, the relatively small sample size and the detailed demographic, clinical, and physiological data collected may increase the risk of participant re-identification. De-identified aggregate study results will be reported in the thesis, scientific publications, and presentations.
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants are randomly assigned in parallel to one of three study groups: sleep hygiene education alone, sleep hygiene education combined with a sensory-based intervention, or sleep hygiene education combined with a behavioral intervention. Each participant remains in the assigned group throughout the six-week intervention period, and outcomes are assessed before and after the intervention.
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| Sensory-Based Sleep Intervention | Behavioral | Participants receive a home-based sensory intervention in addition to sleep hygiene education. The intervention includes inhalation of lavender and orange essential oils before bedtime and exposure to pink noise during the transition to sleep. Participants are instructed to apply a few drops of the essential oils to cotton or gauze placed at an appropriate distance for inhalation, or to disperse the oils into the room using a diffuser. The sensory strategies are introduced by the researcher and are applied regularly in the home environment throughout the six-week intervention period. Adherence is monitored through weekly telephone follow-up. |
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| Behavioral Relaxation Intervention | Behavioral | Participants receive a home-based behavioral relaxation intervention in addition to sleep hygiene education. The intervention consists of progressive muscle relaxation exercises and diaphragmatic breathing exercises performed before bedtime. Participants are provided with an audio recording and written instructions to support standardized practice. Progressive muscle relaxation involves the systematic relaxation of different muscle groups, while diaphragmatic breathing is used to support physiological relaxation. The exercises are practiced regularly throughout the six-week intervention period, and adherence is monitored through weekly telephone follow-up. |
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| Change in WHOQOL-BREF Domain Scores | Quality of life is assessed using the World Health Organization Quality of Life-BREF. The instrument evaluates physical health, psychological health, social relationships, and environmental quality of life. Domain scores are calculated separately, with higher scores indicating better quality of life. Changes in each domain score are evaluated. | Baseline and immediately after completion of the 6-week intervention |
| Change in Occupational Balance Questionnaire-11 Total Score | Occupational balance is assessed using the 11-item Occupational Balance Questionnaire. The total score ranges from 0 to 33. Higher scores indicate better perceived balance in the amount and variation of daily activities. The outcome is the change in the total score from baseline to the post-intervention assessment. | Baseline and immediately after completion of the 6-week intervention |
| Change in Adolescent/Adult Sensory Profile Quadrant Scores | Sensory processing patterns are assessed using the Adolescent/Adult Sensory Profile. The instrument evaluates four patterns: low registration, sensation seeking, sensory sensitivity, and sensation avoiding. Scores are calculated separately for each quadrant. Higher scores indicate more frequent behaviors associated with the relevant sensory processing pattern. | Baseline and immediately after completion of the 6-week intervention |
| Change in Resting Heart Rate Variability Parameters | Resting heart rate variability is recorded using a Polar H10 chest-strap sensor following a 5-minute seated rest period. Parameters include mean RR interval, heart rate, SDNN, RMSSD, pNN50, LF power, HF power, LF/HF ratio, normalized LF and HF power, and autonomic nervous system indices. Changes in each parameter are evaluated. | Baseline and immediately after completion of the 6-week intervention |
| D001523 | Mental Disorders |