Labor PainNCT05130957
The Effect of Clove Oil on Labor Pain
A study testing Massage Application with clove oil and Massage Application without any oil in people with Labor Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The study has two groups. one of them is experimental group that is given massage with clove oil. The other one is control group that is given standard midwifery care. Each group consists of 30 women. We will evaluate their labor pain scores by using Visual Analogue Scale before and after massage application. 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
- What is being tested?
- Massage Application with clove oil and Massage Application without any oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 Sep 2022
- 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
Who may be able to join
- All of volunteer and pregnant women is 18-35 years old.
Who cannot join
- The pregnant women has any obstetrical complications.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital- Maternity Hospital
Ankara, Çankaya
About this study
Official title: The Effect of Massage Applied With Clove Oil on Perceived Labor Pain
The study has two groups. one of them is experimental group that is given massage with clove oil. The other one is control group that is given standard midwifery care. Each group consists of 30 women. We will evaluate their labor pain scores by using Visual Analogue Scale before and after massage application.
Read the detailed description
Labor is a painful process. That's why there are lots of nonpharmacological methods to reduce labor pain. Especially most clinical guide suggests giving massage to pregnant who has labor pain. In the literature, there are a lot of study examining effectiveness of massage techniques. However there is no study about massage application with clove oil on labor pain. The investigators would like to give a massage with clove oil to pregnants to reduce their labor pain. Hereby the investigators will evaluate effectiveness of clove oil.
- Conditions
- Labor Pain
- Being tested
- Massage Application with clove oil, Massage Application without any oil
- Keywords
- labor pain, midwifery, pregnant women, massage
- 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 Application with clove oilOther
The experimental group is given a massage with clove oil,
Massage Application without any oilOther
The control group is given a massage without any oil as a standard midwifery care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The pregnant women in the experimental group are given a massage with clove oil. Receives: Other: Massage Application with clove oil |
| Control Group | Other | The pregnant women in the control group are given a massage without any oil as standard midwifery care Receives: Other: Massage Application without any 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 posted23 Nov 2021
- Study start1 Nov 2021
- Primary completion1 Feb 2022
- Study completion1 Sep 2022
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups as experimental and control.
- 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, Nükhet Kaçar, Ankara City Hospital Bilkent
- Investigators
- Nükhet Kaçar, MSc., Principal investigator, Ankara City Hospital- Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130957
- Sponsor's protocol ID
- AnkaraCHBilkent-MH-NK-01
- Status last verified
- Mar 2023
- First submitted
- 12 Nov 2021
- Last updated
- 7 Mar 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 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Massage Applied With Clove Oil on Perceived Labor Pain
- ClinicalTrials.gov ID
- NCT05130957
- Acronym / sponsor ID
- AnkaraCHBilkent-MH-NK-01
- Conditions
- Labor Pain
- Keywords
- labor pain, midwifery, pregnant women, massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 23 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.
The study has two groups. one of them is experimental group that is given massage with clove oil. The other one is control group that is given standard midwifery care. Each group consists of 30 women. We will evaluate their labor pain scores by using Visual Analogue Scale before and after massage application.
Detailed description
Labor is a painful process. That's why there are lots of nonpharmacological methods to reduce labor pain. Especially most clinical guide suggests giving massage to pregnant who has labor pain. In the literature, there are a lot of study examining effectiveness of massage techniques. However there is no study about massage application with clove oil on labor pain. The investigators would like to give a massage with clove oil to pregnants to reduce their labor pain. Hereby the investigators will evaluate effectiveness of clove oil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two groups as experimental and control.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Massage Application with clove oilThe pregnant women in the experimental group are given a massage with clove oil. |
| Control Group | Other | Other: Massage Application without any oilThe pregnant women in the control group are given a massage without any oil as standard midwifery care |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All of volunteer and pregnant women is 18-35 years old.
Key exclusion criteria (1 listed)
- The pregnant women has any obstetrical complications.
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 Application with clove oilThe experimental group is given a massage with clove oil, | Other | Experimental Group |
| Massage Application without any oilThe control group is given a massage without any oil as a standard midwifery care. | Other | Control Group |
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 7 Mar 2023.
- 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.
Nükhet Kaçar, MSc. principal investigator
Ankara City Hospital- Maternity Hospital
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 Application with clove oil and Massage Application without any 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 1 inclusion and 1 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 7 Mar 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 7 Mar 2023.