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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06338527
Other study ID # 2024YX321
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 26, 2024
Est. completion date June 15, 2024

Study information

Verified date March 2024
Source Weifang Medical University
Contact Jiang Liu, Researcher
Phone +8617667192336
Email Time1987fx@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study was to investigate the effects of aromatherapy on sleep quality and anxiety in patients undergoing chemotherapy for breast cancer.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date June 15, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1) patients diagnosed with breast cancer and receiving chemotherapy; 2) suffering from sleep disorders or PSQI score greater than 5; 3) not using medications such as antidepressants and hypnotics that may affect the observation results; 4) age older than 18 years and volunteered to participate in this study. Exclusion Criteria: 1) Asthma or severe respiratory disease; 2) Allergy to lavender; 3) Cognitive or communication disorders; 4) Breast cancer combined with severe organ dysfunction.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aromatherapy
Lavender oil was used for aromatherapy intervention.
No intervention
No aromatherapy intervention was performed during the period of the study.

Locations

Country Name City State
China Weifang People's Hospital Weifang Shangdong

Sponsors (1)

Lead Sponsor Collaborator
Weifang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep quality The Pittsburgh Sleep Quality Index (PSQI) was used to assess the sleeping quality of the patients. The total score of PSQI ranged from 0-21, with higher scores indicating poor sleep quality. The sleep quality of the patients was assessed at 8 a.m. for one week.
Primary Anxiety Beck Anxiety Inventory (BAI) was used to assess the anxiety level of the patients. The scale consists of 21 entries with a total score ranging from 0 to 63, with higher total scores being associated with more severe levels of anxiety. The anxiety level of the patients was assessed at 8 a.m. for one week.
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