NCT06338527

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

March 23, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 23, 2024

Last Update Submit

March 28, 2024

Conditions

Keywords

Sleep qualityAnxietyAromatherapy

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

The researchers placed 2 drops of lavender oil on gauze in a box each night 30 minutes before the patient went to bed and placed it 15 to 20 centimeters from the pillow.

Other: Aromatherapy

Control group

ACTIVE COMPARATOR

The control group had no aromatherapy intervention during the study period.

Other: No intervention

Interventions

Lavender oil was used for aromatherapy intervention.

Experimental group

No aromatherapy intervention was performed during the period of the study.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weifang People's Hospital

Weifang, Shangdong, 261000, China

Location

Related Publications (1)

  • Zhang F, Cheng L, Qin S, Wang L, Liu Y, Liu Y, Yang J, Fang S, An N, Zhang Y, Liu J. Effect of aromatherapy massage with lavender essential oil on sleep quality, pain, and mental and psychiatric disorders among breast cancer patients undergoing chemotherapy: a randomized controlled trial. Support Care Cancer. 2025 Jul 14;33(8):689. doi: 10.1007/s00520-025-09741-x.

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersAnxiety Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Shirong Fang, M.D.

    Weifang People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Liu, Researcher

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research investigator

Study Record Dates

First Submitted

March 23, 2024

First Posted

March 29, 2024

Study Start

March 26, 2024

Primary Completion

June 1, 2024

Study Completion

June 15, 2024

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations