Labor PainNCT05169138
The Effect Of Lavender Essential Oil On Birth Pain
A study testing Aromatherapy application /massage with lavender oil and Aromatherapy application / inhalation with lavender oil in people with Labor Pain and Aromatherapy, run by Near East University, Turkey at 1 site in Cyprus.
Trial summary
The study was planned as a randomized controlled trial to determine the effect of lavender oil applied to primiparous women by inhalation and massage methods on labor pain. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Aromatherapy
- What is being tested?
- Aromatherapy application /massage with lavender oil and Aromatherapy application / inhalation with lavender oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Jan 2021to 1 Nov 2021
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
INCLUSİON CRİTERİA:
- Single pregnancy
- Primiparous gestational age more than 36 weeks (term)
- Cervical dilatation of at least 3 cm
- Pregnants with 3 uterine contractions in a 10-minute period lasting at least 30 seconds
- Cephalic presentation
- Not receiving analgesics, sedatives or anesthetics during labor,
- Not using induction at birth
EXCLUSİON CRİTERİA:
- Multiparity
- cephalopelvic incompatibility
- third trimester bleeding history
- intrauterine growth retardation
- multiple pregnancy
- breech presentation
- subject's withdrawal from clinical trial
- allergy to aromatic lavender essential oil
- addiction (alcohol, smoking)
- obstetric conditions requiring emergency cesarean section
- infertility history
- previous history of diagnosis of an underlying disease
- induction at birth
Trial locations and contacts
1 site in 1 country.
Cyprus1 site
Near East University / Turkish Republic of Northern Cyprus
Nicosia
About this study
Official title: The Effect Of Lavender Essential Oil And Inhalation And Massage Methods On Birth Pain İn Primiparous Women
The study was planned as a randomized controlled trial to determine the effect of lavender oil applied to primiparous women by inhalation and massage methods on labor pain.
Read the detailed description
In universe of the research; Pregnant women who applied to Adana Seyhan State Hospital's Marsa Gynecology and Obstetrics Additional Service Building and Obstetrics Service and Delivery Room between the dates of the study, accepted to participate in the study voluntarily and who met the research conditions included. Numbers 1-2 of a 6-sided dice determined by the dice rolling system formed the control group (40 pregnant), numbers 3-4 were lavender oil inhalation group (44 pregnant), and numbers 5-6 were lavender oil massage group (37 pregnant).
The research was carried out in three stages for the experimental groups and control groups. First stage; Informed Voluntary Consent Form and Questionnaire were applied to the pregnant women whose groups were determined by the chosen randomization method. Afterwards, for the experimental groups according to the group; 10-minute training sessions were given on the inhalation method or massage method with aromatic lavender essential oil. In the second stage; Data were recorded by dividing the first phase of labor into 3 phases for each group. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied to the experimental groups 6 times, before and 30 minutes after the application. At this stage, no application was made in the control group, the Visual Analog Pain Scales and McGill Melzack Pain Questionnaire were applied at the beginning of each phase, the same forms were repeated after 30 minutes and the data were recorded 6 times in total. In the third stage; In the postpartum period, the study was completed by applying the Postpartum Period Information Collection Form by face-to-face interviews with the experimental groups and the pregnant women in the control group.
- Conditions
- Labor Pain, Aromatherapy
- Being tested
- Aromatherapy application /massage with lavender oil, Aromatherapy application / inhalation with lavender oil
- Keywords
- Labor Pain, Aromatherapy,, Lavender Essential Oil, Aromatherapy with lavender essential oil
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy application /massage with lavender oilOther
The application was applied to 37 pregnant women in total, and the effect of massage with lavender oil on labor pain was investigated.
Aromatherapy application / inhalation with lavender oilOther
The application was applied to 41 pregnant women in total, and the effect of inhalation with lavender oil on labor pain was investigated.
| Study group | Role | What they receive |
|---|---|---|
| massage group with lavender essential oil | Placebo comparator | Pregnant women (n:37) who participated in this group were given an intense massage for at least 10 minutes in each phase during the first phase of labor. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied before and after the application, and the process was completed with a total of 6 measurements. Receives: Other: Aromatherapy application /massage with lavender oil |
| group of inhalations with lavender essential oil | Placebo comparator | Pregnant women (n:44) who participated in this group were administered inhalation with lavender oil at an intensity of at least 10 minutes in each phase during the first phase of labor. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied before and after the application, and the process was completed with a total of 6 measurements. Receives: Other: Aromatherapy application / inhalation with lavender oil |
| control group | No intervention | No application was made to the pregnant women (n:40) who participated in this group in each phase of the first phase of labor. Despite this, the Visual Analog Pain Scale and McGill Melzack Pain Questionnaire, which were applied at the beginning of each phase in order to increase the reliability of the results, were re-evaluated 30 minutes after the measurements, even though there was no application, and the process was completed with a total of 6 measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
It is used to convert some values that cannot be measured numerically into numeric. Two extreme values of the parameter to be evaluated are written at the two ends of a 10 cm line, and the patient is asked to determine where his/her condition is appropriate on this line by drawing a line, putting a dot or placing any sign. For pain; "I have no pain" is written on one end and "very severe pain" is written on the other end and the patient is asked to mark the current situation on the line. The minimum score from the scale is 0, and the maximum score is 10. According to the scale, the highest pain value is expressed with 10 points, while 0 defines the least pain.
Measured: through study completion, an average of 9 month
McGill Melzack Pain Questionnaire
It is a multidimensional pain assessment tool consisting of four parts. At the entrance of the form, personal information of the patient, medical diagnosis-problem, introductory information to determine the location, characteristics, relationship and severity of pain according to the patient's perception are included.
In the McGill Melzack pain questionnaire, the lowest score is 0 and the highest score is 112. 0 denotes the least pain level and the least pain-related discomfort, while 112 denotes the most severe pain and the most pain-related discomfort.
Measured: through study completion, an average of 9 month
Questionnaire
It was developed by the researcher as a result of literature review and includes 30 questions in total. It was aimed to collect information about the sociodemographic and obstetric anamnesis of pregnant women through the form.
Measured: through study completion, an average of 9 month
Postpartum Period Data Collection Form
It was developed by the researcher as a result of literature review and includes 21 questions in total. Via the form; It is aimed to collect information on labor, newborn characteristics, postpartum mother and baby interaction, and evaluation of mothers' satisfaction with massage or inhalation methods.
Measured: through study completion, an average of 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Jan 2021
- Primary completion1 Sep 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The research was planned to define the superiority of inhalation and massage methods applied with lavender oil compared to the control group and each other.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Karatopuk, Near East University, Turkey
- Investigators
- Filiz Yarıcı, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169138
- Sponsor's protocol ID
- 2021/1367
- Status last verified
- Dec 2021
- First submitted
- 26 Nov 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Lavender Essential Oil And Inhalation And Massage Methods On Birth Pain İn Primiparous Women
- ClinicalTrials.gov ID
- NCT05169138
- Acronym / sponsor ID
- 2021/1367
- Conditions
- Labor Pain, Aromatherapy
- Keywords
- Labor Pain, Aromatherapy,, Lavender Essential Oil, Aromatherapy with lavender essential oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 23 Dec 2021 (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.
The study was planned as a randomized controlled trial to determine the effect of lavender oil applied to primiparous women by inhalation and massage methods on labor pain.
Detailed description
In universe of the research; Pregnant women who applied to Adana Seyhan State Hospital's Marsa Gynecology and Obstetrics Additional Service Building and Obstetrics Service and Delivery Room between the dates of the study, accepted to participate in the study voluntarily and who met the research conditions included. Numbers 1-2 of a 6-sided dice determined by the dice rolling system formed the control group (40 pregnant), numbers 3-4 were lavender oil inhalation group (44 pregnant), and numbers 5-6 were lavender oil massage group (37 pregnant).
The research was carried out in three stages for the experimental groups and control groups. First stage; Informed Voluntary Consent Form and Questionnaire were applied to the pregnant women whose groups were determined by the chosen randomization method. Afterwards, for the experimental groups according to the group; 10-minute training sessions were given on the inhalation method or massage method with aromatic lavender essential oil. In the second stage; Data were recorded by dividing the first phase of labor into 3 phases for each group. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied to the experimental groups 6 times, before and 30 minutes after the application. At this stage, no application was made in the control group, the Visual Analog Pain Scales and McGill Melzack Pain Questionnaire were applied at the beginning of each phase, the same forms were repeated after 30 minutes and the data were recorded 6 times in total. In the third stage; In the postpartum period, the study was completed by applying the Postpartum Period Information Collection Form by face-to-face interviews with the experimental groups and the pregnant women in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- The research was planned to define the superiority of inhalation and massage methods applied with lavender oil compared to the control group and each other.
| Arm | Type | Receives |
|---|---|---|
| massage group with lavender essential oil | Placebo comparator | Other: Aromatherapy application /massage with lavender oilPregnant women (n:37) who participated in this group were given an intense massage for at least 10 minutes in each phase during the first phase of labor. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied before and after the application, and the process was completed with a total of 6 measurements. |
| group of inhalations with lavender essential oil | Placebo comparator | Other: Aromatherapy application / inhalation with lavender oilPregnant women (n:44) who participated in this group were administered inhalation with lavender oil at an intensity of at least 10 minutes in each phase during the first phase of labor. Visual Analog Pain Scale and McGill Melzack Pain Questionnaire were applied before and after the application, and the process was completed with a total of 6 measurements. |
| control group | No intervention | –No application was made to the pregnant women (n:40) who participated in this group in each phase of the first phase of labor. Despite this, the Visual Analog Pain Scale and McGill Melzack Pain Questionnaire, which were applied at the beginning of each phase in order to increase the reliability of the results, were re-evaluated 30 minutes after the measurements, even though there was no application, and the process was completed with a total of 6 measurements. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 application /massage with lavender oilThe application was applied to 37 pregnant women in total, and the effect of massage with lavender oil on labor pain was investigated. | Other | massage group with lavender essential oil |
| Aromatherapy application / inhalation with lavender oilThe application was applied to 41 pregnant women in total, and the effect of inhalation with lavender oil on labor pain was investigated. | Other | group of inhalations with lavender essential oil |
Primary outcome
Visual Analog Scale
Time frame: through study completion, an average of 9 month
It is used to convert some values that cannot be measured numerically into numeric. Two extreme values of the parameter to be evaluated are written at the two ends of a 10 cm line, and the patient is asked to determine where his/her condition is appropriate on this line by drawing a line, putting a dot or placing any sign. For pain; "I have no pain" is written on one end and "very severe pain" is written on the other end and the patient is asked to mark the current situation on the line. The minimum score from the scale is 0, and the maximum score is 10. According to the scale, the highest pain value is expressed with 10 points, while 0 defines the least pain.
McGill Melzack Pain Questionnaire
Time frame: through study completion, an average of 9 month
It is a multidimensional pain assessment tool consisting of four parts. At the entrance of the form, personal information of the patient, medical diagnosis-problem, introductory information to determine the location, characteristics, relationship and severity of pain according to the patient's perception are included. In the McGill Melzack pain questionnaire, the lowest score is 0 and the highest score is 112. 0 denotes the least pain level and the least pain-related discomfort, while 112 denotes the most severe pain and the most pain-related discomfort.
Questionnaire
Time frame: through study completion, an average of 9 month
It was developed by the researcher as a result of literature review and includes 30 questions in total. It was aimed to collect information about the sociodemographic and obstetric anamnesis of pregnant women through the form.
Postpartum Period Data Collection Form
Time frame: through study completion, an average of 9 month
It was developed by the researcher as a result of literature review and includes 21 questions in total. Via the form; It is aimed to collect information on labor, newborn characteristics, postpartum mother and baby interaction, and evaluation of mothers' satisfaction with massage or inhalation methods.
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 23 Dec 2021.
- 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.
Filiz Yarıcı study director
Study Director
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 application /massage with lavender oil and Aromatherapy application / inhalation with lavender oil in people with Labor Pain and Aromatherapy, run by Near East University, Turkey at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Dec 2021. 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 Cyprus. 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?
Visual Analog Scale (time frame: through study completion, an average of 9 month). The study lists 4 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 23 Dec 2021.