Labor PainNCT05136066
Effects of Massage With Peppermint Oil on Labor Pain
A study testing massage with peppermint oil in people with Labor Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Birth is a very special experience for a woman and her family. Labor pain is one of the strongest known and defined pains today. In the literature, it has been stated that labor pain is perceived as more severe than chronic pain such as low back pain, cancer pain, phantom pain and postherpetic neuralgia, and acute… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- massage with peppermint oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2021to 15 May 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal pregnant with vertex presentation
- at least 70% 5-6 cm gap in the examination at least 4-5 severe contractions in 10 minutes
- Turkish-speaking
Who cannot join
- Pregnant women with co-morbidities, chronic diseases
- complications related to childbirth
- inactive labor
- anemic, thyroid disease, skin lesions or infection, allergies, multiple pregnancies
- use of any medication
- risky pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Massage With Diluted Peppermint Oil on Visual Analogue Scoring in Reducing Labor Pain
Birth is a very special experience for a woman and her family. Labor pain is one of the strongest known and defined pains today. In the literature, it has been stated that labor pain is perceived as more severe than chronic pain such as low back pain, cancer pain, phantom pain and postherpetic neuralgia, and acute pain such as fracture or laceration.
When birth pain is not controlled, the vicious cycle of stress, fear and pain can continue and affect the mother and fetus negatively.
In this study, our aim is to determine the effect of applying peppermint oil diluted with pure natural olive oil to the abdomen and waist region by massage in labor pain, reducing the labor pain.
Read the detailed description
The study is a Prospective Cross-sectional Case Control study. Pregnant women whose mother tongue is Turkish, who are term pregnant and who are in active labor, who are hospitalized in the delivery room of our hospital for delivery, that is, who have a gap of at least 70% 5-6 cm in the examination and who have at least 4-5 severe contractions in 10 minutes, who have a single, vertex-presented fetus will be included in our work. Pregnant women with co-morbidities, chronic diseases, complications related to childbirth, anemic inactive labor, thyroid disease, skin lesions or infections, allergies, multiple pregnancies, use of any medication, and risky pregnancy will be excluded from the study.
For this, 30 pregnant women who were applied peppermint oil and 30 control group pregnant women who were not applied will be included in the study. Following the signed consent form obtained from our patients, visual analog scoring (VAS) will be provided to the patient during the painful period, and then peppermint oil will be applied to the abdomen and lumbar region where he feels the most pain, with 1/10 diluted peppermint oil by hand massage or with the help of a compress moistened with warm water. After the application, visual pain scoring will be applied to pregnant women again.The study is terminated when sufficient data is obtained.
The data will be entered into the computer in the SPSS program.
- Conditions
- Labor Pain
- Being tested
- massage with peppermint oil
- Keywords
- labor pain, mint oil, Visuel anolgue Scoring
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massage with peppermint oilOther
Peppermint oil diluted with 1/10 pure olive oil will be applied to the pregnant to reduce labor pain.
| Study group | Role | What they receive |
|---|---|---|
| Group massaged with peppermint oil | Experimental | Group of experimental Receives: Other: massage with peppermint oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The scale has 0-10 points.As the point increases the pain score increases
Measured: during labor process, until the labor process is done
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start13 Nov 2021
- Primary completion20 Jan 2023
- Study completion15 May 2023
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.
- More trials run by Ankara City Hospital BilkentThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Two groups with mint oil control group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahime Bedir Fındık, Ankara City Hospital Bilkent
- Investigators
- Rahime Bedir Findik, Dr, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136066
- Sponsor's protocol ID
- AnkaraCHBilkent-MH-RBF-01
- Status last verified
- Jul 2023
- First submitted
- 13 Nov 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Massage With Diluted Peppermint Oil on Visual Analogue Scoring in Reducing Labor Pain
- ClinicalTrials.gov ID
- NCT05136066
- Acronym / sponsor ID
- AnkaraCHBilkent-MH-RBF-01
- Conditions
- Labor Pain
- Keywords
- labor pain, mint oil, Visuel anolgue Scoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 26 Nov 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.
Birth is a very special experience for a woman and her family. Labor pain is one of the strongest known and defined pains today. In the literature, it has been stated that labor pain is perceived as more severe than chronic pain such as low back pain, cancer pain, phantom pain and postherpetic neuralgia, and acute pain such as fracture or laceration.
When birth pain is not controlled, the vicious cycle of stress, fear and pain can continue and affect the mother and fetus negatively.
In this study, our aim is to determine the effect of applying peppermint oil diluted with pure natural olive oil to the abdomen and waist region by massage in labor pain, reducing the labor pain.
Detailed description
The study is a Prospective Cross-sectional Case Control study. Pregnant women whose mother tongue is Turkish, who are term pregnant and who are in active labor, who are hospitalized in the delivery room of our hospital for delivery, that is, who have a gap of at least 70% 5-6 cm in the examination and who have at least 4-5 severe contractions in 10 minutes, who have a single, vertex-presented fetus will be included in our work. Pregnant women with co-morbidities, chronic diseases, complications related to childbirth, anemic inactive labor, thyroid disease, skin lesions or infections, allergies, multiple pregnancies, use of any medication, and risky pregnancy will be excluded from the study.
For this, 30 pregnant women who were applied peppermint oil and 30 control group pregnant women who were not applied will be included in the study. Following the signed consent form obtained from our patients, visual analog scoring (VAS) will be provided to the patient during the painful period, and then peppermint oil will be applied to the abdomen and lumbar region where he feels the most pain, with 1/10 diluted peppermint oil by hand massage or with the help of a compress moistened with warm water. After the application, visual pain scoring will be applied to pregnant women again.The study is terminated when sufficient data is obtained.
The data will be entered into the computer in the SPSS program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two groups with mint oil control group
| Arm | Type | Receives |
|---|---|---|
| Group massaged with peppermint oil | Experimental | Other: massage with peppermint oilGroup of experimental |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- normal pregnant with vertex presentation
- at least 70% 5-6 cm gap in the examination at least 4-5 severe contractions in 10 minutes
- Turkish-speaking
Key exclusion criteria (6 listed)
- Pregnant women with co-morbidities, chronic diseases
- complications related to childbirth
- inactive labor
- anemic, thyroid disease, skin lesions or infection, allergies, multiple pregnancies
- use of any medication
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 |
|---|---|---|
| massage with peppermint oilPeppermint oil diluted with 1/10 pure olive oil will be applied to the pregnant to reduce labor pain. | Other | Group massaged with peppermint oil |
Primary outcome
Visual Analogue Scale
Time frame: during labor process, until the labor process is done
The scale has 0-10 points.As the point increases the pain score increases
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 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Labor Pain
Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
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.
Rahime Bedir Findik, Dr principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage with peppermint oil in people with Labor Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 27 Jul 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 Turkey (Türkiye). 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?
Visual Analogue Scale (time frame: during labor process, until the labor process is done). 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 27 Jul 2023.