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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.
The research data is planned to be collected between January 2023 and November 2023. Data will be collected from elderly individuals from the community. After the elderly individuals who meet the appropriate criteria are informed about the research, their verbal and written consent will be obtained that they agree to participate in the research.
Experimental Group In order to collect the pre-test data of the experimental group, individuals who accept the study will be asked to fill in the Personal Information Form, Sleep Quality Scale and Berg Balance Scale. The forms will be collected after the individuals mark the options closest to them on the forms. It is planned to last approximately 25-30 minutes. It is planned to recommend lavender scent as a nursing intervention to improve sleep quality in individuals with irregular sleep and low sleep quality. Participants in the experimental group will be informed about the effects of lavender scent on sleep and will be given lavender pouches. They will be informed that they should put these lavender pouches in their pillows where they sleep every day and that they should sleep with the lavender pouch for the next month, and that they should not make any changes in their rooms or beds other than the lavender pouch. After the one-month lavender scent application of the experimental group is completed, the post-test data will be collected for the experimental group. After the individuals who gave the closest answer to themselves completed the forms, the post-test data will be collected and the data collection phase of the research will be completed.
Control Group The study will start by collecting the pre-test data of the control group. Individuals who agree to participate in the study will be asked to fill in the Personal Information Form, Sleep Quality Scale and Berg Balance Scale to collect pre-test data. The forms will be collected after the individuals mark the options closest to them on the forms. After collecting the pre-test data, no intervention will be made to the participants for one month. At the end of one month, the control group will be administered the post-test with the same data collection tools.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | No Intervention | No intervention was made to the participants in the control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry lavender flower scent | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Posttest (measurement one month after the pre-test) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berna Bayır | KTO Karatay University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berna Bayır | Karatay | Konya | 42020 | Turkey (Türkiye) |
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Refused to participate (n=18) Did not fulfil the inclusion criteria (n=12)
complementary medicine
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| ID | Title | Description |
|---|---|---|
| FG000 | Lavender Group | The group to which lavender scent was applied using a lavender sachet. |
| FG001 | Control Group | The group to which no intervention was made. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
G-Power (v3.1.9.2) program was used to determine the sample size to be reached.120 elderly individuals were contacted. However, 18 of them refused to participate in the study. Twelve of these did not meet the inclusion criteria.Those included in the lavender group agreed to use lavender scent for the period specified by the researchers. Both the experimental and control groups contributed to the study by completing the measurement tools provided by the researchers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lavender Group | The group to which lavender scent was applied using a lavender sachet. |
| BG001 | Control Group | The group to which no intervention was made. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | This randomised controlled trial involved 90 elderly participants, 45 in the lavender group and 45 in the control group. Data obtained from a total of 90 elderly individuals were analysed. | Posted | Mean | Standard Deviation | score on a scale | Pretest (measurement taken during the initial encounter) |
|
Participants were followed for 1 month for outcome assessment; however, adverse events (including all-cause mortality, serious, and other adverse events) were not monitored or systematically assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lavender Group | 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 sleep with the lavender sachets for the next month, without making any other changes to their rooms or beds. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Professor Berna BAYIR | KTO Karatay University | +905065422424 | berna.bayir23@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2023 | Feb 27, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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|
| 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. |
| Posttest (measurement one month after the pre-test) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Geometric Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The group to which no intervention was made.
|
|
| Primary | 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. | Data obtained from 90 elderly individuals has been included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Pretest (measurement taken during the initial encounter) |
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|
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| Secondary | 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. | Data obtained from 90 elderly individuals has been included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Posttest (measurement one month after the pre-test) |
|
|
|
| Secondary | 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. | Data obtained from 90 elderly individuals has been included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Posttest (measurement one month after the pre-test) |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Group | No intervention was made to the participants in the control group. | 0 | 0 | 0 | 0 | 0 | 0 |
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