Clinical trial NCT06208800: The Effect of Aromatherapy on Sleep and Cognitive Level in the Elderly
Official title: Effects of Inhaled Blend Aromatherapy on Sleep Duration, Sleep Quality, Time to Fall Asleep and Cognitive Level in Elderly People
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Insomnia
Cognitive Impairment
Elderly
Keywords: Aromatherapy
Sleep
Cognitive Functions
Elderly
Insomnia
Peppermint
Palmarosa
Musk sage
Petitgrain
Vetiver
Cedrus
Citrus Paradisi
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research aims to investigate the effect of aromatherapy on sleep duration, sleep quality, falling asleep time and cognitive functions of elderly individuals in the short term and to improve the general health status and quality of life of elderly individuals in the long term.

Detailed description: Due to the aging of the world population, the elderly population is increasing and age-related physiological changes and a number of health problems arise. Aging brings challenges such as chronic diseases, balance disorders, osteoporosis, disorientation, sleep disorders, neurological and psychiatric disorders. Changes during the aging process affect individuals' sleep duration, quality and cognitive level. Insufficient and poor quality sleep can lead to depression, anxiety, pain sensitivity, irritability, suppression of the immune system, decreased mental activity, in short, deterioration of general health and functioning. Sleep problems and some cognitive functions can be treated with pharmacological and non-pharmacological methods, but pharmacological methods can cause serious side effects and complications. Aromatherapy is a complementary alternative treatment method used for the physical, mental and spiritual positive effects of plant-derived essential oils. In our literature review, it was observed that some non-pharmacological approaches (such as massage, listening to music, phototherapy, relaxation exercises and aromatherapy) applied to different populations improved sleep problems and cognitive levels. There are studies in the literature evaluating the effect of aromatherapy, especially aromatherapy applied through massage, on sleep in the elderly, but there is no study examining the effect of inhaled mixture aromatherapy on insomnia, sleep duration, sleep quality, and time to fall asleep. and the interoperation of cognitive functions. However, as mentioned above, sleep problems and daytime sleepiness affect cognitive functions. This research, which was planned to fill this gap in the literature, has a unique value that distinguishes it from other studies on the subject.

The main purpose of the research is to examine the effect of blended aromatherapy applied via inhalation to elderly individuals on sleep duration, sleep quality, time to fall asleep and cognitive functions. For this purpose, an application was made to the elderly care center affiliated with the Ministry of Family and Social Services for research permission. Permission was obtained from the institution to conduct the research. In order to conduct the research, informed consent forms will be obtained from elderly individuals living in the elderly care center who have the ability to understand and answer the questions and those who do not have any knowledge. Those who have a disability to participate in the applications and those who meet the inclusion criteria will be identified and their participation in the research will be ensured. The minimum number of participants planned to be reached in the research was determined as 60. First of all, the elderly individuals will be equally distributed as experimental and control groups by simple randomization method. Then, after the elderly individuals in both groups are informed about the study, the survey and forms will be applied and they will be given a wearable smart watch and an Android mobile phone compatible with this watch to wear on their wrists for 4 days. The researcher will make the elderly in the intervention group smell peppermint and palmarosa oils for 10 minutes at 11:00 during the day for 4 weeks. In addition, the researcher will make the elderly in the experimental group smell the essential oil mixture of vetiver, cedar, clary sage, grapefruit and petitgrain for 10 minutes at 21:30 in the evening before going to bed on the same day. Essential oil mixture inhalation will not be applied to the control group. The researcher planned to re-administer the questionnaires and forms to the experimental and control groups at the beginning of the application and at the end of the 4th week. It is planned to give individuals in both the experimental group and the control group a wearable smart watch worn on the wrist and an Android mobile phone compatible with the smart watch until the end of the 4th week. Thanks to the application on the Android mobile phone, the data from the smart watch will be transferred to the computer. The obtained values will be transferred to the Social Sciences Statistical Package (SPSS) 22.0 statistical analysis program and the necessary analyzes will be performed.

It is planned to provide materials and consumables in the first three months of the research, to obtain data in seven months, and to interpret the results with statistical analysis in the last two months. The data obtained as a result of the research will pave the way for the development of new strategies to improve the sleep quality and cognitive levels of elderly individuals. The research aims to investigate the effects of aromatherapy on the sleep duration, sleep quality, time to fall asleep and cognitive functions of elderly individuals in the short term. In the long term, it will contribute to improving the general health status of elderly individuals, increasing their quality of life and improving their general health status. This research, which is one of the rare studies in the literature, will shed light on future research in this field and has the power to appear as articles in important international journals and to be presented as papers at scientific meetings.

Eligibility criteria: Inclusion Criteria:

* 65 -85 years of age
* Not having a condition that prevents him/her from participating in the practices (such as pain, severe infection)
* Acceptance to participate in the research,
* Not having a psychiatric problem that prevents them from working and not being diagnosed with mental deficiency,
* To be capable of understanding and answering the questions,
* No hearing or speech impairment and no problem with smell that would hinder communication,
* Any respiratory system disease (such as asthma, COPD), allergic skin disease (such as eczema) and no history of allergy to plants,
* No known allergy to the essential oils to be used,
* At the time of the study, any of the traditional and complementary medicine practices is not using it,
* Daytime sleepiness (Epworth Sleepiness Scale Score ≥ 11),
* Pittsburgh Sleep Quality Index (PUKI) score ≥ 5

Exclusion Criteria:

* Antidepressants, antihistamines, diuretics, hypnotics, benzodiazepines that affect sleep quality and the use of narcotic analgesics,
* Body Mass Index (BMI) ≥ 30,
* 5 and above, expressing that he/she has pain,
* Allergy to any odor or plant,
* Presence of a respiratory disease such as asthma and chronic obstructive pulmonary disease

Primary outcomes:
measure: Elderly Introduction Form
timeFrame: Four Weeks
measure: Epworth Sleepiness Scale
timeFrame: Four Weeks
measure: Pittsburgh Sleep Quality Index-PSQI
timeFrame: Four Weeks
measure: Blessed Orientation Memory Concentration Test (BOBKT)
timeFrame: Four Weeks
measure: Wearable Smart Device Worn on the Wrist
timeFrame: Four Weeks
measure: Android Mobile Phone
timeFrame: Four Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Medipol University
Study officials:
affiliation: İstanbul Medipol University
name: Belçim EDE SARIKAYA, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Üsküdar University
name: Sebahat ATEŞ, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: İstanbul Medipol University
name: Ayşe Arzu SAYIN ŞAKUL, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Üsküdar University
name: Tuğba KAMAN, PhD
role: PRINCIPAL_INVESTIGATOR
References: