Preoperative AnxietyLAV-ORTHONCT07513831
Effect of Lavender Aromatherapy on Preoperative Anxiety, Stress, and Depression in Orthopedic Surgery Patients
A study testing Lavender Essential Oil Inhalation in people with Preoperative Anxiety and Psychological Stress, run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Anxiety, Psychological Stress, Depressive Symptoms
- What is being tested?
- Lavender Essential Oil Inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteJordan
- Study dates
- 1 Mar 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Preoperative Anxiety, Psychological Stress, Depressive Symptoms, Orthopedic Surgery Patients
- Being tested
- Lavender Essential Oil Inhalation
- Keywords
- Anxiety, Depression, Stress, Orthopedic Surgery, Aromatherapy, Non-pharmacological Intervention
- Medical subject headings
- Stress, Psychological, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender Essential Oil InhalationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: The data were collected from baseline (within 2 hours before intervention) to immediately after the 20-minute inhalation session on the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Mar 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment with two groups: lavender aromatherapy versus control (room air only).
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Zaytoonah University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andaleeb M. Abu Kamel, Al-Zaytoonah University of Jordan
- Investigators
- Andaleeb Abu Kamel, PDH, Study director, Faculty of Nursing, Al-Zaytoonah University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513831
- Sponsor's protocol ID
- AZUJ-NUR-AROMA-ORTHO-2024
- Acronym
- LAV-ORTHO
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Al-Zaytoonah University of Jordan: https://www.zuj.edu.jo
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aromatherapy With Lavender Essential Oil on Preoperative Anxiety, Stress, and Depression Among Patients Undergoing Orthopedic Surgeries: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07513831
- Acronym / sponsor ID
- LAV-ORTHO / AZUJ-NUR-AROMA-ORTHO-2024
- Conditions
- Preoperative Anxiety, Psychological Stress, Depressive Symptoms, Orthopedic Surgery Patients
- Keywords
- Anxiety, Depression, Stress, Orthopedic Surgery, Aromatherapy, Non-pharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Al-Zaytoonah University of JordanUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment with two groups: lavender aromatherapy versus control (room air only).
| Arm | Type | Receives |
|---|---|---|
| Lavender Aromatherapy | Experimental | Other: Lavender Essential Oil InhalationPatients in this arm receive inhalation aromatherapy with 100% lavender essential oil in addition to routine preoperative nursing care before orthopedic surgery. |
| Control - Room Air | No intervention | –Patients inhale room air only and receive routine preoperative nursing care, with no aromatherapy administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender Essential Oil InhalationPatients 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. | Other | Lavender Aromatherapy |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- BackgroundAl-Zaytoonah University of Jordan: https://www.zuj.edu.jo
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andaleeb Abu Kamel, PDH study director
Faculty of Nursing, Al-Zaytoonah University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Essential Oil Inhalation in people with Preoperative Anxiety and Psychological Stress, run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07513831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.