Labor PainNCT04367038
Endorphin at Labor Pain and Acupressure
A study testing Warm Acupressure, Cold Acupressure , Conventional Acupressure in people with Labor Pain, run by Serap ÖZTÜRK ALTINAYAK at 1 site in Turkey (Türkiye).
Trial summary
This study was performed to determine the impact of different acupressure procedures, performed on women's hands during labor, on endorphin levels and labor pain perception. The sample consisted of 140 pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Warm Acupressure, Cold Acupressure , Conventional Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2019to 8 Jan 2020
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a primipara
- Having intact membranes
- No skin diseases (such as urticaria...),
- No use of narcotic drugs
- Having a term pregnancy
- Having a single fetus at vertex position
Show all 14Show fewer
- Planning to have vaginal delivery
- Having contractions and ongoing regular augmentation
- Having recent augmentation starting periods
- Being in the latent phase (0-3 cm dilatation)
- Having no history of high-risk pregnancy
- Not using analgesic drugs to reduce pain during delivery
- Having no systemic and neurologic diseases
- Having no contraction anomaly (hypotonic or hypertonic contractions)
Who cannot join
- Having any of the above criteria.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Research and Training Hospital of Tokat Gaziosmanpaşa University
Tokat Province
About this study
Official title: The Impact of Different Acupressure Procedures Performed on the Hand During Labor on Endorphin Levels and Labor Pain Perception: A Randomised Controlled Trial
This study was performed to determine the impact of different acupressure procedures, performed on women's hands during labor, on endorphin levels and labor pain perception.
The sample consisted of 140 pregnant women. The study was conducted with three experimental groups and one control group, each including 35 pregnant women. Conventional acupressure and warm and cold acupressure procedures were performed on the Large Intestinal 4 energy meridian zone acupressure point of the experimental group. No procedures were performed on the women in the control group. Data were collected using a "Personal Information Form", "Labor Intervention Follow-up Form", "Visual Analog Scale" and "Verbal Category Scale".
The comparison between the experimental and control groups indicated that the conventional acupressure procedure was effective in reducing labor pain and that the warm acupressure procedure increased endorphin levels.
- Conditions
- Labor Pain
- Being tested
- Warm Acupressure, Cold Acupressure , Conventional Acupressure
- Keywords
- acupressure, labor pain, Midwifery, pregnant women, endorphins, warm acupressure, cold acupressure
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Acupressure, Cold Acupressure , Conventional AcupressureOther
Acupressure is non-invasive, safe and effective.
| Study group | Role | What they receive |
|---|---|---|
| Warm Acupressure Procedure Group | Experimental | Latent phase Visual Analog Scale and Verbal Category Scale I given as pretest First venous blood sample taken Active phase The first warm acupressure procedure was performed for ten minutes on the Large Intestinal 4 energy meridian zone acupressure point on the non-dominant hand. This process was repeated three more times at one-hour intervals.
Visual Analog Scale II and Verbal Category Scale II were measured at the end of the active phase Transition phase The second warm acupressure procedure was performed three times at one-hour intervals A 30-minute break was given Visual Analog Scale III and Verbal Category Scale III were performed Second venous blood sample taken Receives: Other: Warm Acupressure, Cold Acupressure , Conventional Acupressure |
| Cold Acupressure Procedure Group | Experimental | Latent phase Visual Analog Scale I and Verbal Category Scale I given as pretest First venous blood sample taken Active phase The first cold acupressure procedure was performed for ten minutes on the Large Intestinal 4 energy meridian zone acupressure point on the non-dominant hand. This process was repeated three more times at one-hour intervals.
Visual Analog Scale II and Verbal Category Scale II were measured at the end of the active phase Transition phase The second cold acupressure procedure was performed three times at one-hour intervals A 30-minute break was given Visual Analog Scale III and Verbal Category Scale III were performed Second venous blood sample taken Receives: Other: Warm Acupressure, Cold Acupressure , Conventional Acupressure |
| Conventional Acupressure Group | Experimental | Latent phase Visual Analog Scale I and Verbal Category Scale I given as pretest First venous blood sample taken Active phase Conventional acupressure was performed for 30 minutes on the Large Intestinal 4 energy meridian zone acupressure point on the non-dominant hand. This process was repeated twice more at one-hour intervals.
Visual Analog Scale II and Verbal Category Scale II were measured at the end of the active phase Transition phase The second conventional acupressure procedure was performed twice at one-hour intervals A 30-minute break was given Visual Analog Scale III and Verbal Category Scale III were performed Second venous blood sample taken Receives: Other: Warm Acupressure, Cold Acupressure , Conventional Acupressure |
| Control Group | No intervention | Latent phase Visual Analog Scale I and Verbal Category Scale I given as pretest First venous sample taken Active phase No procedure other than the routine clinical practices were carried out. Visual Analog Scale II and Verbal Category Scale II were measured at the end of the active phase Transition phase No procedure other than the normal clinical routines was conducted Visual Analog Scale III and Verbal Category Scale III were performed. Second venous blood sample taken |
What is being measured
The primary outcome is the main question the study is designed to answer.
labor pain
pain scale
Measured: through study completion, an average of 1month
endorphin levels
physiological parameter
Measured: through study completion, an average of 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start25 Apr 2019
- Primary completion31 Oct 2019
- Study completion8 Jan 2020
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serap ÖZTÜRK ALTINAYAK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Serap ÖZTÜRK ALTINAYAK, Tokat Gaziosmanpasa University
- Investigators
- Hava Özkan, PhD, Study director, Atatürk University Faculty of Health Science, Department of Midwifery,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367038
- Sponsor's protocol ID
- 25.09.2018-04/2
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I want it published in a journal first.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Acupressure Procedures Performed on the Hand During Labor on Endorphin Levels and Labor Pain Perception: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04367038
- Acronym / sponsor ID
- 25.09.2018-04/2
- Conditions
- Labor Pain
- Keywords
- acupressure, labor pain, Midwifery, pregnant women, endorphins, warm acupressure, cold acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Serap ÖZTÜRK ALTINAYAKUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 29 Apr 2020 (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.
This study was performed to determine the impact of different acupressure procedures, performed on women's hands during labor, on endorphin levels and labor pain perception.
The sample consisted of 140 pregnant women. The study was conducted with three experimental groups and one control group, each including 35 pregnant women. Conventional acupressure and warm and cold acupressure procedures were performed on the Large Intestinal 4 energy meridian zone acupressure point of the experimental group. No procedures were performed on the women in the control group. Data were collected using a "Personal Information Form", "Labor Intervention Follow-up Form", "Visual Analog Scale" and "Verbal Category Scale".
The comparison between the experimental and control groups indicated that the conventional acupressure procedure was effective in reducing labor pain and that the warm acupressure procedure increased endorphin levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Warm Acupressure Procedure Group | Experimental | Other: Warm Acupressure, Cold Acupressure , Conventional AcupressureLatent phase Visual Analog Scale and Verbal Category Scale I given as pretest First venous blood sample taken Active phase The first warm acupressure procedure was performed for ten minutes on the Large Intestinal 4 energy meridian zone acupressure point on the non-dominant hand. This process was repeated three more times at one-hour intervals. Visual Analog Scale II and Verbal Category Scale II were measured at the end of the active phase Transition phase The second warm acupressure procedure was performed three times at one-hour intervals A 30-minute break was given Visual Analog Scale III and Verbal Category Scale III were performed Second venous blood sample taken |
| Cold Acupressure Procedure Group | Experimental | Other: Warm Acupressure, Cold Acupressure , Conventional AcupressureLatent phase Visual Analog Scale I and Verbal Category Scale I given as pretest First venous blood sample taken Active phase The first cold acupressure procedure was performed for ten minutes on the Large Intestinal 4 energy meridian zone acupressure point on the non-dominant hand. This process was repeated three more times at one-hour intervals. Visual Analog Scale II and Verbal Category Scale II were measured at the end of the active phase Transition phase The second cold acupressure procedure was performed three times at one-hour intervals A 30-minute break was given Visual Analog Scale III and Verbal Category Scale III were performed Second venous blood sample taken |
| Conventional Acupressure Group | Experimental | Other: Warm Acupressure, Cold Acupressure , Conventional AcupressureLatent phase Visual Analog Scale I and Verbal Category Scale I given as pretest First venous blood sample taken Active phase Conventional acupressure was performed for 30 minutes on the Large Intestinal 4 energy meridian zone acupressure point on the non-dominant hand. This process was repeated twice more at one-hour intervals. Visual Analog Scale II and Verbal Category Scale II were measured at the end of the active phase Transition phase The second conventional acupressure procedure was performed twice at one-hour intervals A 30-minute break was given Visual Analog Scale III and Verbal Category Scale III were performed Second venous blood sample taken |
| Control Group | No intervention | –Latent phase Visual Analog Scale I and Verbal Category Scale I given as pretest First venous sample taken Active phase No procedure other than the routine clinical practices were carried out. Visual Analog Scale II and Verbal Category Scale II were measured at the end of the active phase Transition phase No procedure other than the normal clinical routines was conducted Visual Analog Scale III and Verbal Category Scale III were performed. Second venous blood sample taken |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Being a primipara
- Having intact membranes
- No skin diseases (such as urticaria...),
- No use of narcotic drugs
- Having a term pregnancy
Key exclusion criteria (2 listed)
- Having any of the above criteria.
- -
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 |
|---|---|---|
| Warm Acupressure, Cold Acupressure , Conventional AcupressureAcupressure is non-invasive, safe and effective. | Other | Cold Acupressure Procedure Group, Conventional Acupressure Group, Warm Acupressure Procedure Group |
Primary outcome
labor pain
Time frame: through study completion, an average of 1month
pain scale
endorphin levels
Time frame: through study completion, an average of 1month
physiological parameter
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 29 Apr 2020.
- Individual participant dataSharing planned: No. I want it published in a journal first.
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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.
Hava Özkan, PhD study director
Atatürk University Faculty of Health Science, Department of Midwifery,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Acupressure, Cold Acupressure , Conventional Acupressure in people with Labor Pain, run by Serap ÖZTÜRK ALTINAYAK 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 14 inclusion and 2 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 29 Apr 2020. 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?
labor pain (time frame: through study completion, an average of 1month). 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 29 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.