- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513831
Effect of Lavender Aromatherapy on Preoperative Anxiety, Stress, and Depression in Orthopedic Surgery Patients (LAV-ORTHO)
Effect of Aromatherapy With Lavender Essential Oil on Preoperative Anxiety, Stress, and Depression Among Patients Undergoing Orthopedic Surgeries: A Quasi-Experimental Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This quasi-experimental study was designed to determine the effect of inhalation aromatherapy with lavender essential oil on preoperative anxiety, stress, and depression among patients undergoing orthopedic surgeries in Jordan. Orthopedic operations are among the most painful surgical procedures and are frequently associated with high levels of psychological distress, which can negatively affect postoperative outcomes, length of hospital stay, and patient satisfaction. Non-pharmacological interventions such as aromatherapy have been proposed as simple, low-cost strategies to improve patients' psychological well-being before surgery.
The study was conducted in two large governmental referral hospitals, Al-Bashir Hospital in Amman and Al Hussein Al-Salt New Hospital in Al-Salt, both of which have high volumes of orthopedic surgeries. A convenience sample of adult patients (≥18 years) scheduled for major orthopedic procedures (including total knee replacement [TKR], total hip replacement [THR], and fracture fixation) was recruited based on predefined inclusion and exclusion criteria. Inclusion criteria required the ability to read and write Arabic, absence of apparent cognitive impairment, and willingness to participate, while patients with respiratory problems, allergy to lavender oil, pregnancy, or severe non-orthopedic pain were excluded.
Participants were allocated into two non-randomized groups: an intervention group and a control group. The intervention group received lavender inhalation aromatherapy by breathing in 100% lavender essential oil, applied as 2 drops on a cotton pad placed approximately 5 cm from the nose, for 20 minutes during the preoperative period. The control group inhaled room air only and received routine preoperative nursing care without any aromatherapy. Both groups completed the Depression Anxiety Stress Scale-21 (DASS-21), a validated 21-item self-report instrument that measures the severity of anxiety, stress, and depression symptoms, before and after the intervention.
A total of 128 patients participated in the study, with 64 patients in the intervention group and 64 in the control group. Data were collected using structured questionnaires and analyzed using IBM Statistical Package for the Social Sciences (SPSS) software, version 26. Appropriate descriptive and inferential statistics, including independent t-tests, were used to compare pre- and post-intervention scores within and between groups. The main outcome measures were changes in DASS-21 anxiety, stress, and depression subscale scores from pre- to post-intervention.
The findings indicated that lavender inhalation aromatherapy led to significant reductions in preoperative anxiety, stress, and depression scores in the intervention group compared with the control group, which did not receive aromatherapy. These results support the use of lavender aromatherapy as a complementary, non-pharmacological nursing intervention that is easy to administer, cost-effective, and well tolerated by patients undergoing orthopedic surgery. The study suggests that integrating aromatherapy into routine preoperative care may contribute to better psychological outcomes and potentially improve overall surgical recovery in this population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amman, Jordan, 11623
- Al-Bashir Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lavender Aromatherapy
Patients in this arm receive inhalation aromatherapy with 100% lavender essential oil in addition to routine preoperative nursing care before orthopedic surgery.
|
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.
|
|
No Intervention: Control - Room Air
Patients inhale room air only and receive routine preoperative nursing care, with no aromatherapy administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Preoperative Anxiety Score (DASS-21)
Time Frame: From baseline (within 2 hours before intervention) to immediately after the 20-minute inhalation session on the day of surgery.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Preoperative Depression Score (DASS-21)
Time Frame: The data were collected from baseline (within 2 hours before intervention) to immediately after the 20-minute inhalation session on the day of surgery.
|
Change in preoperative depression score, measured using the Depression Anxiety Stress Scale-21 (DASS-21).
The DASS-21 depression subscale ranges from 0 to 21, with higher scores indicating more severe depressive symptoms and lower scores indicating better psychological status.
The outcome is defined as the change in the depression subscale score from pre-intervention (baseline) to post-intervention, comparing the lavender aromatherapy group with the control group in patients undergoing orthopedic surgery.
|
The data were collected from baseline (within 2 hours before intervention) to immediately after the 20-minute inhalation session on the day of surgery.
|
Collaborators and Investigators
Investigators
- Study Director: Andaleeb Abu Kamel, PDH, Faculty of Nursing, Al-Zaytoonah University of Jordan
Publications and helpful links
General Publications
- Al-Zaytoonah University of Jordan: https://www.zuj.edu.jo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZUJ-NUR-AROMA-ORTHO-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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