Post-operative PainNCT06387849
Aromatherapy Effect on Pain and Anxiety After C-section
A study testing Aromatherapy in people with Post-operative Pain and Post-operative Anxiety, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
A prospective randomized triple blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over a period of four months and 10 days between April 2023 and August 2023. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain, Post-operative Anxiety
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTunisia
- Study dates
- 21 Apr 2023to 31 Aug 2023
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All women who gave birth by cesarean section under spinal anesthesia in the obstetrics and gynecology department at the Ben Arous regional hospital who met the following criteria were included in this study:
- Age between 18 and 45 years old
- Term of pregnancy at the time of delivery ≥ 37 weeks of Gestation.
- A minimum level of primary education as a prerequisite to answer the questions (in particular the STAI items).
- Classified ASA 1 or 2 of the American Society of Anesthesiology (ASA) classification.
- Having no history of cancer or chronic pain.
- Free from any psychiatric pathology.
- And having not presented any intra- or post-operative complications.
Who cannot join
- The investigators excluded patients in our study:
- Having given birth to a stillborn or a suffering newborn requiring transfer to neonatal intensive care.
- Having received painkillers in the post-operative period.
- Having olfactory disorders.
- Having a substance abuse problem.
- Having a known allergy to lavender or other aromatic plants.
- who did not agree to participate in the study or who did not continue all stages of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aromatherapy Using Lavender Essential Oil on Pain and Anxiety After C-section: a Randomized Controlled Trial
A prospective randomized triple blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over a period of four months and 10 days between April 2023 and August 2023.
The aim of this study was to evaluate the effectiveness of lavender aromatherapy on postoperative pain and anxiety after cesarean section under spinal anesthesia in Tunisian women.
- Conditions
- Post-operative Pain, Post-operative Anxiety
- Being tested
- Aromatherapy, Placebo
- Keywords
- Cesarean, Pain, Anxiety, Aromatherapy, Lavender
- Medical subject headings
- Pain, Postoperative, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
women enrolled in the experimental group received aromatherapy with lavender essential oil (EO) through dry inhalation (inhalation via a cotton support soaked in a few drops of EO)
PlaceboOther
women enrolled in the placebo group received ihaled a cotton support soaked in a few drops of distilled water
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy group | Experimental | Two to twelve hours after undergoing C-section, the women enrolled in the experimental arm benefited from aromatherapy with lavender essential oil (EO): The patients were invited to inhale cotton balls, soaked separately with three drops of the EO at a distance of 10 centimeters for 30 minutes. Receives: Other: Aromatherapy |
| Placebo | Placebo comparator | Two to twelve hours after undergoing C-section, the women enrolled in the placebo arm were invited to inhale cotton balls, soaked separately with three drops of the distilled water at a distance of 10 centimeters for 30 minutes. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain level
the investigator evaluated the Post-operative pain level using Visual analogue scale( patient at rest and after ambulation). The score ranges from 0 (no pain at all) to 10 (the worst imaginable pain). the higher the score is, the worst the outcome is.
Measured: two to twelve hours after surgery
Post-operative anxiety level
the investigator evaluated the Post-operative anxiety level using the " State Trait Anxiety Inventory (STAI)forme Y ". The score ranges from 20 to 80. Higher scores are associated with higher levels of anxiety (worse outcome)
Measured: two to twelve hours after surgery
Secondary outcomes (5)
Heart Rate (HR)
Heart Rate in beat per minute (bpm),
Measured: two to twelve hours after surgery
Systolic Blood Pressure (SBP)
Systolic Blood Pressure (SBP) in millimetres of mercury (mmHg)
Measured: two to twelve hours after surgery
Diastolic Blood Pressure (DBP)
Diastolic Blood Pressure (DBP) in millimetres of mercury (mmHg)
Measured: two to twelve hours after surgery
Respiratory Rate (RR)
Respiratory Rate (RR) in cycle per minute (cpm)
Measured: two to twelve hours after surgery
Pulsatile Oxygen Saturation
Pulsatile Oxygen Saturation (SPO2) in percentage (%).
Measured: two to twelve hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start21 Apr 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
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 Post-operative PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesrine Souayeh, University Tunis El Manar
- Investigators
- Hajer Bettaieb, Professor, Study director, University of Tunis el Manar, Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387849
- Sponsor's protocol ID
- 03/2023
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nouira M, Souayeh N, Kanzari SA, Rouis H, Lika A, Mbarki C, Rahali FZ, Bettaieb H. Aromatherapy Using Lavender Oil Effectiveness on Pain and Anxiety After C-Section: A Randomized Controlled Trial. J Epidemiol Glob Health. 2024 Dec;14(4):1536-1544. doi: 10.1007/s44197-024-00305-6. Epub 2024 Oct 14.
PubMed 39400653
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aromatherapy Using Lavender Essential Oil on Pain and Anxiety After C-section: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06387849
- Acronym / sponsor ID
- 03/2023
- Conditions
- Post-operative Pain, Post-operative Anxiety
- Keywords
- Cesarean, Pain, Anxiety, Aromatherapy, Lavender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 29 Apr 2024 (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.
A prospective randomized triple blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over a period of four months and 10 days between April 2023 and August 2023.
The aim of this study was to evaluate the effectiveness of lavender aromatherapy on postoperative pain and anxiety after cesarean section under spinal anesthesia in Tunisian women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy group | Experimental | Other: AromatherapyTwo to twelve hours after undergoing C-section, the women enrolled in the experimental arm benefited from aromatherapy with lavender essential oil (EO): The patients were invited to inhale cotton balls, soaked separately with three drops of the EO at a distance of 10 centimeters for 30 minutes. |
| Placebo | Placebo comparator | Other: PlaceboTwo to twelve hours after undergoing C-section, the women enrolled in the placebo arm were invited to inhale cotton balls, soaked separately with three drops of the distilled water at a distance of 10 centimeters for 30 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- All women who gave birth by cesarean section under spinal anesthesia in the obstetrics and gynecology department at the Ben Arous regional hospital who met the following criteria were included in this study:
Key exclusion criteria (7 listed)
- Having given birth to a stillborn or a suffering newborn requiring transfer to neonatal intensive care.
- Having received painkillers in the post-operative period.
- Having olfactory disorders.
- Having a substance abuse problem.
- Having a known allergy to lavender or other aromatic plants.
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 |
|---|---|---|
| Aromatherapywomen enrolled in the experimental group received aromatherapy with lavender essential oil (EO) through dry inhalation (inhalation via a cotton support soaked in a few drops of EO) | Other | Aromatherapy group |
| Placebowomen enrolled in the placebo group received ihaled a cotton support soaked in a few drops of distilled water | Other | Placebo |
Primary outcome
Post-operative pain level
Time frame: two to twelve hours after surgery
the investigator evaluated the Post-operative pain level using Visual analogue scale( patient at rest and after ambulation). The score ranges from 0 (no pain at all) to 10 (the worst imaginable pain). the higher the score is, the worst the outcome is.
Post-operative anxiety level
Time frame: two to twelve hours after surgery
the investigator evaluated the Post-operative anxiety level using the " State Trait Anxiety Inventory (STAI)forme Y ". The score ranges from 20 to 80. Higher scores are associated with higher levels of anxiety (worse outcome)
5 secondary outcomes
Heart Rate (HR)
Time frame: two to twelve hours after surgery
Systolic Blood Pressure (SBP)
Time frame: two to twelve hours after surgery
Diastolic Blood Pressure (DBP)
Time frame: two to twelve hours after surgery
Respiratory Rate (RR)
Time frame: two to twelve hours after surgery
Pulsatile Oxygen Saturation
Time frame: two to twelve hours after 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 29 Apr 2024.
- Derived from this study: PubMed 39400653Nouira M, Souayeh N, Kanzari SA, Rouis H, Lika A, Mbarki C, Rahali FZ, Bettaieb H. Aromatherapy Using Lavender Oil Effectiveness on Pain and Anxiety After C-Section: A Randomized Controlled Trial. J Epidemiol Glob Health. 2024 Dec;14(4):1536-1544. doi: 10.1007/s44197-024-00305-6. Epub 2024 Oct 14.
- Individual participant dataSharing planned: No
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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.
Hajer Bettaieb, Professor study director
University of Tunis el Manar, Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy in people with Post-operative Pain and Post-operative Anxiety, run by University Tunis El Manar at 1 site in Tunisia.
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 8 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 29 Apr 2024. 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 Tunisia. 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. Some participants in this study may receive a placebo. 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?
Post-operative pain level (time frame: two to twelve hours after surgery). The study lists 2 primary outcomes in all. 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 NCT06387849, 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 29 Apr 2024.