The Effect of Aromatherapy on Sleep and Cognitive Level in the Elderly

NCT06208800 | Unknown

• 1 other identifier: E-95961207-604.01.01-3755
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Cognitive Impairment; Elderly

Keywords

Aromatherapy; Sleep; Cognitive Functions; Elderly; Insomnia; Peppermint; Palmarosa; Musk sage; Petitgrain; Vetiver; Cedrus; Citrus Paradisi

Outcome Measures

Primary Outcomes (6)

• Elderly Introduction Form

  The Elderly Introduction Form is a form prepared by the researcher by scanning the literature and contains information about the sociodemographic characteristics of individuals (age, gender, BMI, chronic disease, etc.) (Her and Cho, 2021; Aydın Yıldırım and Kitiş, 2020).

  Four Weeks

• Epworth Sleepiness Scale

  It is a scale used to indicate daytime sleepiness and sleepiness tendency during the day. It consists of 8 questions in total. Each question is filled in by the individual himself, giving 0-3 points. In this survey, the individual's likelihood of falling asleep in certain situations on a normal day when he or she is not overly tired is questioned. The scoring method is the same for all questions; if there is no probability of falling asleep, 0 is given, if there is a low probability of falling asleep, 1, if there is a medium probability, 2 and if there is a high probability, 3 points are given. If the total score is between 0-10, it indicates normal condition for healthy individuals, between 11-14, it indicates mild sleepiness, between 15-17, it indicates moderate sleepiness, and if it is 18 and above, it indicates the presence of excessive daytime sleepiness.

  Four Weeks

• Pittsburgh Sleep Quality Index-PSQI

  PSQI , is a safe and consistent questionnaire that evaluates the amount of sleep, sleep quality, presence and severity of sleep disorder in individuals in the last month, and was adapted into Turkish by Ağargün by. PSQI consists of 12 questions in total. The evaluation score of an item is between 0-3. In this way, the total score obtained from all 7 components gives the total PSQI score. The total score obtained varies between 0-21. The higher the score, the worse the sleep quality. A score greater than five indicates poor sleep quality

  Four Weeks

• Blessed Orientation Memory Concentration Test (BOBKT)

  The test was developed by Blessed, Tomlinson and Roth in 1968 and consists of 26 items. The first and second questions are related to time orientation and ask for the current month and year. It is then made to memorize a memory item containing information (a fictitious first name, a surname, a fictitious street name, an imaginary number, and a fictitious city name). The fourth and fifth questions are questions designed to measure attention. In the fourth question, the patient is asked to count back from twenty, one by one. In the fifth question, it is expected that the person will count the months backwards. Then, the last question is the memory measurement question, in which the individual is asked about the memorized memory item. An increase in the score indicates a decrease in cognitive functions. This test, which has been standardized into Turkish, can be applied to individuals at all educational levels since it is not related to the year of education (Akça-Kalem et al., 2002).

  Four Weeks

• Wearable Smart Device Worn on the Wrist

  Wearable technologies, which have become very popular especially in the field of healthcare, monitor the health status of patients remotely and send the data to the physician without the need for outpatient clinic visits. In this way, unnecessary procedures are prevented, costs are reduced and the quality of health services is increased.These wearable smart devices are devices that allow continuous measurement every second. In this research, it is planned to objectively obtain individuals' falling asleep time, awake time, bedtime, wake-up time, REM sleep, light and deep sleep hours, snoring and total sleep time throughout the night, with a smart watch worn on the wrist It is planned to analyze these recorded data with a statistical program and to interpret and transfer them in detail in the findings section of the research.

  Four Weeks

• Android Mobile Phone

  They are Android devices that are compatible with the watch required for the operation of wrist-worn smart watches and the transfer of data from the smart watch.

  Four Weeks

Study Arms (2)

Experimental group to which the essential oil mixture will be applied

EXPERIMENTAL

Thirty elderly individuals will be included in the experimental group. The elderly individuals in the intervention group were given essential oil mixtures in 5 ml bottles prepared by the expert aromatherapist and the researcher, and it was decided to inhale these essential oils by dropping 5 drops on cotton wool for 10 minutes each for 4 weeks.

Other: Blend Aromatherapy

Experimental group without essential oil mixture.Control group

NO INTERVENTION

Thirty elderly individuals will be included in the control group. This group will not be intervened, only questionnaires will be administered.

Interventions

Blend Aromatherapy OTHER

Inhalation of a mixture of essential oils of peppermint, palmarosa for 10 minutes at 11:00 am during the day and vetiver, cedar, clary sage, musk sage, grapefruit and petitgrain for 10 minutes at 21:30 pm before bedtime for 4 weeks

Experimental group to which the essential oil mixture will be applied

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Antidepressants, antihistamines, diuretics, hypnotics, benzodiazepines that affect sleep quality and the use of narcotic analgesics,
• Body Mass Index (BMI) ≥ 30,
• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

İstanbul Medipol University

Istanbul, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Belçim EDE SARIKAYA, MSc

  İstanbul Medipol University

  PRINCIPAL INVESTIGATOR

• Sebahat ATEŞ, PhD

  Üsküdar University

  PRINCIPAL INVESTIGATOR

• Ayşe Arzu SAYIN ŞAKUL, PhD

  İstanbul Medipol University

  PRINCIPAL INVESTIGATOR

• Tuğba KAMAN, PhD

  Üsküdar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Belçim EDE SARIKAYA, MSc

CONTACT

05327177333; belcim.ede@medipol.edu.tr

Sebahat ATEŞ, PhD

CONTACT

05337647604; sebahat.ates@uskudar.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine Nurse MSc, Lecturer, Investigator

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: January 17, 2024
• Study Start: January 30, 2024
• Primary Completion: March 29, 2024
• Study Completion: June 30, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)