NCT05377697

Brief Summary

With aging, deterioration in sleep structure and balance occurs. In particular, individuals over the age of 65 often have sleep problems, and non-pharmacological methods used to solve this problem are much more reliable than pharmacological methods. It is important for nurses who contribute most to their care to regulate and facilitate sleep, which is one of the basic needs of people. Thanks to this study, it is planned to solve the sleep-related problems of elderly individuals by using the sedative and relaxing effect of the lavender plant, which is used in many areas, thus increasing their quality of life, and it is planned to prevent falls by increasing their physical balance controls. This study aims to determine the effect of lavender scent recommended for the elderly in Konya on sleep quality and physical balance. This research is a randomized experimental design with pretest-posttest control group. The research is planned to be carried out between January 2023 and November 2023. The population of the research consists of elderly individuals living in society. In order to determine the sample size, power analysis will be made using the G-Power (v3.1.9.2) program. Personal Information Form and Pittsburgh Sleep Quality Index will be used in data collection. The data obtained as a result of the research; It will be analyzed with IBM SPSS program. p\<0.05 will be considered statistically significant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

April 28, 2022

Results QC Date

August 27, 2025

Last Update Submit

March 24, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pittsburgh Sleep Quality İndex (PSQI)

    The total score has a value between 0-21, a high total score indicates poor sleep quality. A total PSQI score of less than 5 indicates the good sleep quality and a score of more than 5 indicates the poor sleep quality

    Pretest (measurement taken during the initial encounter)

  • Berg Balance Scala (BBS)

    Items include daily activities such as static sitting and standing balance, as well as transferring, turning, picking up objects, etc. Each item is rated on a scale of 0 to 4. The maximum total score is 56. A high score indicates good balance.

    Pretest (measurement taken during the initial encounter)

Secondary Outcomes (2)

  • Pittsburgh Sleep Quality İndex (PSQI)

    Posttest (measurement one month after the pre-test)

  • Berg Balance Scala (BBS)

    Posttest (measurement one month after the pre-test)

Study Arms (2)

Lavender group

EXPERIMENTAL

Participants in the experimental group were informed about the effects of lavender scent on sleep and were given lavender sachets. They were instructed to place these lavender sachets on their pillows every day and to sleep with the lavender sachets for the following month, and were advised not to make any changes to their rooms or beds other than the lavender sachets.

Other: Dry lavender flower scent

Control group

NO INTERVENTION

No intervention was made to the participants in the control group.

Interventions

Participants in the experimental group will be informed about the effects of lavender scent on sleep and lavender sachets will be given. They will be informed that they should put these lavender sachets in their pillows every day and sleep with a lavender sachet for the next month, and that they should not make any changes in their rooms or beds other than the lavender sachet.

Lavender group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Volunteer to participate in the study.
  • Working in shifts for at least three months
  • Individuals who do not have a disease that would prevent research and communication will be included in the research.

You may not qualify if:

  • Lavender allergy
  • Patients with asthma, bronchitis
  • Use of drug(s) that induce sleep
  • Individuals who have received a medical diagnosis for attention will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berna Bayır

Karatay, Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
Associate Professor Berna BAYIR
Organization
KTO Karatay University

Study Officials

  • Berna Bayır

    KTO Karatay University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 17, 2022

Study Start

April 23, 2022

Primary Completion

July 30, 2023

Study Completion

September 15, 2023

Last Updated

April 13, 2026

Results First Posted

April 13, 2026

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations