NCT07513831

Brief Summary

This study evaluates whether inhalation aromatherapy with lavender essential oil can reduce anxiety, stress, and depression in adult patients before orthopedic surgery in Jordan. Orthopedic procedures are often associated with high levels of psychological distress, which may worsen pain, delay recovery, and prolong hospital stay. Aromatherapy is a simple, non-drug intervention that may help patients feel calmer and better prepared for surgery. The study was conducted in two large public hospitals, Al-Bashir Hospital in Amman and Al Hussein Al-Salt New Hospital in Al-Salt. Adult patients (18 years or older) scheduled for major orthopedic operations who could read and write Arabic and agreed to participate were invited to join the study. Patients with respiratory problems, an allergy to lavender oil, pregnancy, or severe non-orthopedic pain were excluded. Participants were assigned to one of two groups. In the intervention group, patients inhaled 100% lavender essential oil for 20 minutes from a cotton pad placed about 5 cm from the nose before surgery. In the control group, patients inhaled room air only and received routine preoperative nursing care. All participants completed a short questionnaire, the 21-item Depression Anxiety Stress Scale-21 (DASS-21), before and after the intervention to measure their levels of anxiety, stress, and depression. A total of 128 patients took part, with 64 in the lavender group and 64 in the control group. The results showed that patients who received lavender aromatherapy had lower anxiety, stress, and depression scores before surgery compared with those who did not receive aromatherapy. These findings suggest that lavender inhalation aromatherapy may be a safe, low-cost, and easy-to-use option to improve psychological well-being for orthopedic surgery patients in the preoperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

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
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
Last Updated

April 9, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 31, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

AnxietyDepressionStressOrthopedic SurgeryAromatherapyNon-pharmacological Intervention

Outcome Measures

Primary Outcomes (1)

  • Change in Preoperative Anxiety Score (DASS-21)

    Change in preoperative anxiety score, measured using the Depression Anxiety Stress Scale-21 (DASS-21). The DASS-21 anxiety subscale ranges from 0 to 21, with higher scores indicating more severe anxiety and lower scores indicating better psychological status. The outcome is defined as the change in the anxiety subscale score from pre-intervention (baseline) to post-intervention in patients undergoing orthopedic surgery.

    From baseline (within 2 hours before intervention) to immediately after the 20-minute inhalation session on the day of surgery.

Secondary Outcomes (1)

  • Change in Preoperative Depression Score (DASS-21)

    The data were collected from baseline (within 2 hours before intervention) to immediately after the 20-minute inhalation session on the day of surgery.

Study Arms (2)

Lavender Aromatherapy

EXPERIMENTAL

Patients in this arm receive inhalation aromatherapy with 100% lavender essential oil in addition to routine preoperative nursing care before orthopedic surgery.

Other: Lavender Essential Oil Inhalation

Control - Room Air

NO INTERVENTION

Patients inhale room air only and receive routine preoperative nursing care, with no aromatherapy administered.

Interventions

Patients inhale 100% lavender essential oil applied as two drops on a cotton pad placed approximately 5 cm from the nose for 20 minutes during the preoperative period, in addition to routine preoperative nursing care.

Lavender Aromatherapy

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 years or older.
  • Undergoing major orthopedic surgeries (e.g., total knee replacement, total hip replacement, fracture reduction and fixation).
  • Able to read and write in Arabic.
  • Male or female patients.
  • No apparent cognitive deficit.
  • Willing to participate and able to provide written informed consent.

You may not qualify if:

  • Younger than 18 years of age.
  • Unable to read or write Arabic.
  • Mentally unqualified or with obvious cognitive impairment.
  • History of respiratory problems (e.g., asthma, chronic obstructive pulmonary disease) that may be affected by inhalation of essential oils.
  • Known allergy or hypersensitivity to lavender essential oil.
  • Pregnant women.
  • Suffering from severe pain not related to the orthopedic surgery (e.g., burn pain).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Bashir Hospital

Amman, 11623, Jordan

Location

Related Publications (1)

  • Al-Zaytoonah University of Jordan: https://www.zuj.edu.jo

    BACKGROUND

MeSH Terms

Conditions

Stress, PsychologicalDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Andaleeb Abu Kamel, PDH

    Faculty of Nursing, Al-Zaytoonah University of Jordan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Open-label quasi-experimental study with no masking.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment with two groups: lavender aromatherapy versus control (room air only).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Faculty of Nursing

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 7, 2026

Study Start

March 1, 2024

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

April 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because this is a single-center academic master's thesis with limited resources and no plan or infrastructure for external data sharing.

Locations