PainNCT06114472
The Impact of Preoperative Aromatherapy Upon Time to First Analgesia Request After Cesarean Section
A study testing aromatherapy blend containing Lavender in people with Pain, run by Assiut University at 1 site in Egypt.
Trial summary
one of the main aims of anesthesia is to reduce postoperative pain. However, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding . Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- aromatherapy blend containing Lavender
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Oct 2023to 30 May 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 40 years
- Body mass index (BMI) of 18-35 kg/m2
- Patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- Patients scheduled for elective cesarean section.
Who cannot join
- Patient refusal
- Allergy to local anaesthetics
- Anosmia
- Coagulopathy,
- Chronic pain syndromes
- Prolonged opioid medication
- Patients who received any analgesic 24 h before surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Emad Zarief Kamel Said
Asyut, 71111
Emad Z Kamel, M.D., +201007046058, emadzarief@yahoo.com
About this study
Official title: The Impact of Preoperative Aromatherapy Upon Time to First Analgesia Request and Consumption After Cesarean Section; Randomized Clinical Trial
one of the main aims of anesthesia is to reduce postoperative pain. However, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding
. Recent studies have indicated interest in using complementary therapies such as heat and cold therapy, hypnotism.
Read the detailed description
Pain is amongst the most common problems after surgery
(1). Pain is an unpleasant sensory and emotional experience, which is associated with the real or probably damage of tissue. Unrelieved postoperative pain in addition to creating fears in the surgical patients, it makes adverse psychological impact on them
- The uncontrolled postoperative pain will make a lot of acute and chronic effects, including systemic mediators, hypercoagulability, postoperative immunosuppression, and delayed wound healing
- So, one of the main aims of anesthesia is to reduce postoperative pain. However, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding. Recent studies have indicated interest in using complementary therapies such as heat and cold therapy, hypnotism.
- Conditions
- Pain
- Being tested
- aromatherapy blend containing Lavender
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromatherapy blend containing LavenderDrug
hree drops of aromatherapy blend containing Lavender essence 10% were poured on cotton in cast containers, and the patient was asked to inhale it for 5 minutes from a distance of 10 cm
| Study group | Role | What they receive |
|---|---|---|
| Group A aromatherapy | Active comparator | three drops of aromatherapy blend containing Lavender essence 10% were poured on cotton in cast containers, and the patient was asked to inhale it for 5 minutes from a distance of 10 cm Receives: Drug: aromatherapy blend containing Lavender |
| Group B Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first analgesia request
time to first analgesia request in minutes
Measured: 24 hours
Secondary outcomes (1)
Total daily consumption of analgesia
intravenous keteloac total consumption in the 1st 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start31 Oct 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114472
- Sponsor's protocol ID
- IRB8888888888
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McQuay H, Derry S, Wiffen P, Moore A, Eccleston C. Postoperative pain management: number-needed-to-treat approach versus procedure-specific pain management approach. Pain. 2013 Jan;154(1):180. doi: 10.1016/j.pain.2012.10.007. Epub 2012 Oct 22. No abstract available.
PubMed 23200259Gupta A, Kaur K, Sharma S, Goyal S, Arora S, Murthy RS. Clinical aspects of acute post-operative pain management & its assessment. J Adv Pharm Technol Res. 2010 Apr;1(2):97-108.
PubMed 22247838Sheikhan F, Jahdi F, Khoei EM, Shamsalizadeh N, Sheikhan M, Haghani H. Episiotomy pain relief: Use of Lavender oil essence in primiparous Iranian women. Complement Ther Clin Pract. 2012 Feb;18(1):66-70. doi: 10.1016/j.ctcp.2011.02.003. Epub 2011 Mar 16.
PubMed 22196577
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Preoperative Aromatherapy Upon Time to First Analgesia Request and Consumption After Cesarean Section; Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06114472
- Acronym / sponsor ID
- IRB8888888888
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 2 Nov 2023 (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.
one of the main aims of anesthesia is to reduce postoperative pain. However, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding
. Recent studies have indicated interest in using complementary therapies such as heat and cold therapy, hypnotism.
Detailed description
Pain is amongst the most common problems after surgery
(1). Pain is an unpleasant sensory and emotional experience, which is associated with the real or probably damage of tissue. Unrelieved postoperative pain in addition to creating fears in the surgical patients, it makes adverse psychological impact on them
- The uncontrolled postoperative pain will make a lot of acute and chronic effects, including systemic mediators, hypercoagulability, postoperative immunosuppression, and delayed wound healing
- So, one of the main aims of anesthesia is to reduce postoperative pain. However, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding. Recent studies have indicated interest in using complementary therapies such as heat and cold therapy, hypnotism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A aromatherapy | Active comparator | Drug: aromatherapy blend containing Lavenderthree drops of aromatherapy blend containing Lavender essence 10% were poured on cotton in cast containers, and the patient was asked to inhale it for 5 minutes from a distance of 10 cm |
| Group B Control | No intervention | –No intervention |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 20 and 40 years
- Body mass index (BMI) of 18-35 kg/m2
- Patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- Patients scheduled for elective cesarean section.
Key exclusion criteria (7 listed)
- Patient refusal
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 |
|---|---|---|
| aromatherapy blend containing Lavenderhree drops of aromatherapy blend containing Lavender essence 10% were poured on cotton in cast containers, and the patient was asked to inhale it for 5 minutes from a distance of 10 cm | Drug | Group A aromatherapy |
Primary outcome
time to first analgesia request
Time frame: 24 hours
time to first analgesia request in minutes
1 secondary outcome
Total daily consumption of analgesia
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 23200259McQuay H, Derry S, Wiffen P, Moore A, Eccleston C. Postoperative pain management: number-needed-to-treat approach versus procedure-specific pain management approach. Pain. 2013 Jan;154(1):180. doi: 10.1016/j.pain.2012.10.007. Epub 2012 Oct 22. No abstract available.
- Background: PubMed 22247838Gupta A, Kaur K, Sharma S, Goyal S, Arora S, Murthy RS. Clinical aspects of acute post-operative pain management & its assessment. J Adv Pharm Technol Res. 2010 Apr;1(2):97-108.
- Background: PubMed 22196577Sheikhan F, Jahdi F, Khoei EM, Shamsalizadeh N, Sheikhan M, Haghani H. Episiotomy pain relief: Use of Lavender oil essence in primiparous Iranian women. Complement Ther Clin Pract. 2012 Feb;18(1):66-70. doi: 10.1016/j.ctcp.2011.02.003. Epub 2011 Mar 16.
- 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.
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 blend containing Lavender in people with Pain, run by Assiut University at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first analgesia request (time frame: 24 hours). 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 NCT06114472, which also lists 3 linked publications.
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 7 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.