Postoperative Nausea and VomitingNCT06060418
Effect of Lavender Aromatherapy on Post-Operative Nausea and Vomiting Among Laparotomy Patients
A study testing aromtherapy in people with Postoperative Nausea and Vomiting, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
Post-operative nausea and vomiting are critical problems that occur commonly after the administration of general anesthesia, which can lead to serious health complications such as hemorrhage, electrolyte imbalance and ultimate shock. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- aromtherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2024to Oct 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those patients: -
- with 18 -65 years
- both Male and Female
- who received general anesthesia for surgery
- who experience nausea and vomiting within 24hr after surgery
- who hemodynamically stable
Who cannot join
- Those patients
- • who move to ICU after the Procedure
- with history of substance addiction
- having history of pre-op nausea and vomiting
- with history of motion sickness
- who start Oral or Naso Gastric Feed after surgery
Show all 10Show fewer
- having history of Lung disease, ant type of allergy or infection
- who need laparotomy reversal short after the procedure
- Who received antiemetic before surgery
- who went to any type of complication during the procedure not included in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lavender Aromatherapy on Post-Operative Nausea and Vomiting Among Laparotomy Patients At DHQ Sheikhupura Punjab, Pakistan
Post-operative nausea and vomiting are critical problems that occur commonly after the administration of general anesthesia, which can lead to serious health complications such as hemorrhage, electrolyte imbalance and ultimate shock. To prevent these complications, antiemetic drugs are often administered, but they can cause side effects as well as increased healthcare costs. As concerns regarding the side effects of antiemetic drugs have grown, there has been an increased interest in using non-pharmacologic interventions, such as aromatherapy, as an alternative approach to preventing post-operative nausea and vomiting. It involves the therapeutic use of essential oils, and lavender essential oil, in particular, is commonly used for various digestive problems including nausea, and vomiting. Therefore, a key question for a health care professional is how to prevent post-operative nausea and vomiting in best possible manner? To address this question, a study will be conducted in District Head Quarter Sheikhupura, aiming to evaluate the effectiveness of lavender essential oil aromatherapy in reducing post-operative nausea and vomiting among patients admitted for laparotomy under general anesthesia. This study will be a Randomized control trial with the study population consisting of admitted patients after laparotomy under general anesthesia. The sample size will be 70, who will be divided into two groups, each consisting of 35 participants. A convenience sampling technique will be employed for the recruitment of participants. After that, the participants will be randomized into control and intervention groups by computer-generated table numbers in accordance with the inclusion criteria that is, 18-65 age, both genders, laparotomy under general anesthesia, clinically stable, and susceptive to post-op nausea and vomiting within 24hrs following the surgery. whereas, the patients with respiratory diseases, allergies, infections, reversal laparotomy within short duration, having any kind of addiction, those who move to the intensive care unit, those with a history of motion sickness, history of pre-op nausea and vomiting and those who start oral or NG feed before 24hrs will not be part of this study. The data will be analyzed by using Statistical Package for Social Sciences version 22.
Read the detailed description
Study Design:
Randomized Control trial( RCT)
Study population:
Patients undergoing laparotomy under general anesthesia
Setting:
This study will be carried out at the Institute of Nursing, University of Health Sciences Lahore in collaboration with DHQ Sheikhupura Punjab, Pakistan. This hospital offers 24/7 services in emergency, medicine, surgery, gynecology and pediatrics etc.
Sample Size:
The sample size for each group is 35 and total is 70.
Sampling Technique and Randomization:
A non-probability convenience sampling approach will be utilized for patient enrollment. patients will be randomly assigned to either the intervention or control group through computer-generated table numbers.
Data Collection Procedure and Method of Intervention; Upon receiving approval from the Institutional Review Board of the University of Health Sciences Lahore, formal authorization will be sought from DHQ. Eligible participants will be identified and selected in accordance with predetermined inclusion and exclusion criteria. After explaining the study purpose, the researcher will obtain informed written consent before their surgical procedure. Upon patients' arrival to the HDU following their laparotomy, those who present complaints of postoperative nausea and vomiting will be subject to randomization into either the intervention or control group. This randomization will be executed using computer-generated table numbers. First, the researcher will gather pertinent demographic information from the enrolled participants.
Adequate guarantees of confidentiality shall be extended to all participants.
Method of Intervention:
After deciding the participant of intervention group the intervention will be started if NRS score is > 1 for nausea and with the 1st episode of vomiting.
The researcher will soak a 4×4 cm sterile gauze pad with 0.2 ml equivalent to 2 drops of 10% Lavender essential oil and will suspended the soaked gauze at a distance of 10cm from the patient's nose with the help of forcep, and he or she will have asked to inhale its scent for 5 min. 15 and 40 minutes after the beginning of the aromatherapy treatment, the researcher will measure the nausea and vomiting scores by using the standardized tool. During this entire 40 minutes the researcher will strictly monitor the participant's condition. If the nausea score will be still higher than 1 or vomiting persists the participants will be noted as failure of treatment and move to standard care and the control group received standard care against the complaint of nausea and vomiting.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- aromtherapy
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromtherapyOther
aromatherapy with essential oil is being used as a non-pharmacological nursing intervention within the health care setting. This approach aims to manage the patient's discomfort and alleviate the symptoms of postoperative nausea and vomiting. One of the most beneficial oils is Lavender Essential Oil (LEO), which is used to treat a variety of digestive issues.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | After deciding on the participant of the intervention group the researcher will start the protocol of intervention The researcher will soak a 4×4 cm sterile gauze pad with 0.2 ml equivalent to 2 drops of 10% Lavender essential oil and will suspend the soaked gauze at a distance of 10cm from the patient's nose with the help of forceps, and he or she will have asked to inhale its scent for 5 min. 15 and 40 minutes after the beginning of the aromatherapy treatment, the researcher will measure the nausea and vomiting scores by using the standardized tool. During this entire 40 minutes, the researcher will strictly monitor the participant's condition. If the nausea score is still higher than 1 or the vomiting persists the participants will be noted as failure of treatment and move to standard care. Receives: Other: aromtherapy |
| Control group | No intervention | The control group received standard care against the complain of nausea and vomiting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of postoperative nausea Intensity
When a patient encounters nausea within the initial 24 hours subsequent to the laparotomy, the researcher will adopt the Numeric Rating Scale (NRS) to quantify the intensity of the experienced nausea.
The NRS is a one-dimensional quantitative 11-point pain rating scale that has also been validated to detect nausea by using the content validity method, and its score is 1 which is appropriate to measure the nausea intensity. The researcher will operate this scale by using the verbal scale because self-assessed nausea scores from the NRS and the verbal scale correlated well as rSpearman = 0.79. The researcher will ask the patient to select a number from 0 to 10 that best describes the intensity of their nausea at that precise moment.
Measured: with in 24 hour after the surgery
Measurement of postoperative Vomiting frequency and severity
in scenarios where a patient reports episodes of vomiting during the initial 24-hour postoperative period, the researcher will utilize the Likert scale to assess both the frequency and severity of these vomiting incidents.
Vomiting will be assessed by using a Likert Scale that was also validated on 10% of the sample size. The CVI was 1 and Cronbach alpha was 0.79 which is appropriate to measure the severity of vomiting. The researcher will rate the severity of vomiting as 0 to 4, with 0 representing no vomiting and 4 representing severe vomiting. The number of occurrences indicates the severity (0 = no episode, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5 or more episodes)
Measured: with in 24 hour after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study startOct 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe 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
- Model description
- After deciding the participant of intervention group the researcher will start the protocol of intervention The intervention will start if NRS score is \> 1 for nausea and with the 1st episode of vomiting. The researcher will soak a 4×4 cm sterile gauze pad with 0.2 ml equivalent to 2 drops of 10% Lavender essential oil and will suspended the soaked gauze at a distance of 10cm from the patient's nose with the help of forcep, and he or she will have asked to inhale its scent for 5 min. 15 and 40 minutes after the beginning of the aromatherapy treatment, the researcher will measure the nausea and vomiting scores by using the standardized tool. During this entire 40 minutes the researcher will strictly monitor the participant's condition. If the nausea score will be still higher than 1 or vomiting persists the participants will be noted as failure of treatment and move to standard care and the control group received standard care against the complain of nausea and vomiting.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nosheen Siddique, University of Health Sciences Lahore
- Investigators
- Nosheen Siddique, MSN, Principal investigator, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060418
- Sponsor's protocol ID
- Aroma RCT 2023
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to share the data with other researchers after the analysis of the results. This will help the researchers to identify the gaps and further research covers the limitation of this study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lavender Aromatherapy on Post-Operative Nausea and Vomiting Among Laparotomy Patients At DHQ Sheikhupura Punjab, Pakistan
- ClinicalTrials.gov ID
- NCT06060418
- Acronym / sponsor ID
- Aroma RCT 2023
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 29 Sep 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.
Post-operative nausea and vomiting are critical problems that occur commonly after the administration of general anesthesia, which can lead to serious health complications such as hemorrhage, electrolyte imbalance and ultimate shock. To prevent these complications, antiemetic drugs are often administered, but they can cause side effects as well as increased healthcare costs. As concerns regarding the side effects of antiemetic drugs have grown, there has been an increased interest in using non-pharmacologic interventions, such as aromatherapy, as an alternative approach to preventing post-operative nausea and vomiting. It involves the therapeutic use of essential oils, and lavender essential oil, in particular, is commonly used for various digestive problems including nausea, and vomiting. Therefore, a key question for a health care professional is how to prevent post-operative nausea and vomiting in best possible manner? To address this question, a study will be conducted in District Head Quarter Sheikhupura, aiming to evaluate the effectiveness of lavender essential oil aromatherapy in reducing post-operative nausea and vomiting among patients admitted for laparotomy under general anesthesia. This study will be a Randomized control trial with the study population consisting of admitted patients after laparotomy under general anesthesia. The sample size will be 70, who will be divided into two groups, each consisting of 35 participants. A convenience sampling technique will be employed for the recruitment of participants. After that, the participants will be randomized into control and intervention groups by computer-generated table numbers in accordance with the inclusion criteria that is, 18-65 age, both genders, laparotomy under general anesthesia, clinically stable, and susceptive to post-op nausea and vomiting within 24hrs following the surgery. whereas, the patients with respiratory diseases, allergies, infections, reversal laparotomy within short duration, having any kind of addiction, those who move to the intensive care unit, those with a history of motion sickness, history of pre-op nausea and vomiting and those who start oral or NG feed before 24hrs will not be part of this study. The data will be analyzed by using Statistical Package for Social Sciences version 22.
Detailed description
Study Design:
Randomized Control trial( RCT)
Study population:
Patients undergoing laparotomy under general anesthesia
Setting:
This study will be carried out at the Institute of Nursing, University of Health Sciences Lahore in collaboration with DHQ Sheikhupura Punjab, Pakistan. This hospital offers 24/7 services in emergency, medicine, surgery, gynecology and pediatrics etc.
Sample Size:
The sample size for each group is 35 and total is 70.
Sampling Technique and Randomization:
A non-probability convenience sampling approach will be utilized for patient enrollment. patients will be randomly assigned to either the intervention or control group through computer-generated table numbers.
Data Collection Procedure and Method of Intervention; Upon receiving approval from the Institutional Review Board of the University of Health Sciences Lahore, formal authorization will be sought from DHQ. Eligible participants will be identified and selected in accordance with predetermined inclusion and exclusion criteria. After explaining the study purpose, the researcher will obtain informed written consent before their surgical procedure. Upon patients' arrival to the HDU following their laparotomy, those who present complaints of postoperative nausea and vomiting will be subject to randomization into either the intervention or control group. This randomization will be executed using computer-generated table numbers. First, the researcher will gather pertinent demographic information from the enrolled participants.
Adequate guarantees of confidentiality shall be extended to all participants.
Method of Intervention:
After deciding the participant of intervention group the intervention will be started if NRS score is > 1 for nausea and with the 1st episode of vomiting.
The researcher will soak a 4×4 cm sterile gauze pad with 0.2 ml equivalent to 2 drops of 10% Lavender essential oil and will suspended the soaked gauze at a distance of 10cm from the patient's nose with the help of forcep, and he or she will have asked to inhale its scent for 5 min. 15 and 40 minutes after the beginning of the aromatherapy treatment, the researcher will measure the nausea and vomiting scores by using the standardized tool. During this entire 40 minutes the researcher will strictly monitor the participant's condition. If the nausea score will be still higher than 1 or vomiting persists the participants will be noted as failure of treatment and move to standard care and the control group received standard care against the complaint of nausea and vomiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- After deciding the participant of intervention group the researcher will start the protocol of intervention The intervention will start if NRS score is > 1 for nausea and with the 1st episode of vomiting. The researcher will soak a 4×4 cm sterile gauze pad with 0.2 ml equivalent to 2 drops of 10% Lavender essential oil and will suspended the soaked gauze at a distance of 10cm from the patient's nose with the help of forcep, and he or she will have asked to inhale its scent for 5 min. 15 and 40 minutes after the beginning of the aromatherapy treatment, the researcher will measure the nausea and vomiting scores by using the standardized tool. During this entire 40 minutes the researcher will strictly monitor the participant's condition. If the nausea score will be still higher than 1 or vomiting persists the participants will be noted as failure of treatment and move to standard care and the control group received standard care against the complain of nausea and vomiting.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: aromtherapyAfter deciding on the participant of the intervention group the researcher will start the protocol of intervention The researcher will soak a 4×4 cm sterile gauze pad with 0.2 ml equivalent to 2 drops of 10% Lavender essential oil and will suspend the soaked gauze at a distance of 10cm from the patient's nose with the help of forceps, and he or she will have asked to inhale its scent for 5 min. 15 and 40 minutes after the beginning of the aromatherapy treatment, the researcher will measure the nausea and vomiting scores by using the standardized tool. During this entire 40 minutes, the researcher will strictly monitor the participant's condition. If the nausea score is still higher than 1 or the vomiting persists the participants will be noted as failure of treatment and move to standard care. |
| Control group | No intervention | –The control group received standard care against the complain of nausea and vomiting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those patients: -
- with 18 -65 years
- both Male and Female
- who received general anesthesia for surgery
- who experience nausea and vomiting within 24hr after surgery
Key exclusion criteria (10 listed)
- Those patients
- • who move to ICU after the Procedure
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 |
|---|---|---|
| aromtherapyaromatherapy with essential oil is being used as a non-pharmacological nursing intervention within the health care setting. This approach aims to manage the patient's discomfort and alleviate the symptoms of postoperative nausea and vomiting. One of the most beneficial oils is Lavender Essential Oil (LEO), which is used to treat a variety of digestive issues. | Other | Intervention Group |
Primary outcome
Measurement of postoperative nausea Intensity
Time frame: with in 24 hour after the surgery
When a patient encounters nausea within the initial 24 hours subsequent to the laparotomy, the researcher will adopt the Numeric Rating Scale (NRS) to quantify the intensity of the experienced nausea. The NRS is a one-dimensional quantitative 11-point pain rating scale that has also been validated to detect nausea by using the content validity method, and its score is 1 which is appropriate to measure the nausea intensity. The researcher will operate this scale by using the verbal scale because self-assessed nausea scores from the NRS and the verbal scale correlated well as rSpearman = 0.79. The researcher will ask the patient to select a number from 0 to 10 that best describes the intensity of their nausea at that precise moment.
Measurement of postoperative Vomiting frequency and severity
Time frame: with in 24 hour after the surgery
in scenarios where a patient reports episodes of vomiting during the initial 24-hour postoperative period, the researcher will utilize the Likert scale to assess both the frequency and severity of these vomiting incidents. Vomiting will be assessed by using a Likert Scale that was also validated on 10% of the sample size. The CVI was 1 and Cronbach alpha was 0.79 which is appropriate to measure the severity of vomiting. The researcher will rate the severity of vomiting as 0 to 4, with 0 representing no vomiting and 4 representing severe vomiting. The number of occurrences indicates the severity (0 = no episode, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5 or more episodes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: Yes. There is a plan to share the data with other researchers after the analysis of the results. This will help the researchers to identify the gaps and further research covers the limitation of this study.
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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.
Nosheen Siddique, MSN principal investigator
University of Health Sciences Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aromtherapy in people with Postoperative Nausea and Vomiting, run by University of Health Sciences Lahore at 1 site in Pakistan.
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 10 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 25 Sep 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 Pakistan. 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?
Contact Nosheen Siddique, MSN (+92 3323028885, nosheensiddique244@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of postoperative nausea Intensity (time frame: with in 24 hour after the 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?
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 25 Sep 2024.