Labor PainNeuNCT06057116
The Effect of Massage and Acupressure on Labor Pain
A study testing massage in people with Labor Pain, run by Near East University, Turkey at 1 site in Turkey (Türkiye).
Trial summary
This research was conducted in accordance with the experimental research design to determine the effect of acupuncture and massage, which are non-pharmacological methods used in the treatment of labor pain, on the latent, active and transition stages of the first stage of labor. On labor pain and birth satisfaction. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 15 Jun 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
İnclusion: Having a single fetus, Expecting spontaneous birth, Without Pregnancy Composition, No systemic disease, Those who voluntarily agreed to participate in the research.
Exclusion: With systemic disease multiple pregnancies People who do not want to participate in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Massage and Acupressure on Labor Pain and Birth Satisfaction
This research was conducted in accordance with the experimental research design to determine the effect of acupuncture and massage, which are non-pharmacological methods used in the treatment of labor pain, on the latent, active and transition stages of the first stage of labor. On labor pain and birth satisfaction. Burhan Nalbantoğlu State Hospital and Near East Hospital. There are three groups in the research sample: acupuncture, massage and control groups. A total of 66 people were reached, 22 people in each group. Massage and acupuncture were applied to the intervention groups, while pregnant women in the control group were not intervened other than routine hospital practices. Cervical dilatation was applied for 3-4, 5-7 and 8-10 cm, and massage was applied for 10 minutes each, for a total of 30 minutes. When cervical dilatation was 3-4, 5-7 and 8-10 cm, acupressure was applied for 1 minute each. The pain level perceived by the pregnant woman was evaluated with the Visual Comparison Scale (VAS), and her satisfaction with the birth was evaluated with the Birth Satisfaction Scale (DME). In comparing the Birth Satisfaction Scale scores and Postpartum Pain VAS Scores, the normal distribution of the data was examined with the Kolmogorov-Smirnov test, Shapiro-Wilk test and skewness-kurtosis values and it was determined that it showed a normal distribution, ANOVA was applied. Tukey test was used in further analysis for comparisons. ANCOVA was applied to compare the amount of pain changes at the beginning and end of the latent, active and transition phases according to participant groups.
Read the detailed description
The research will be carried out at the Near East Hospital and Nicosia Burhan Nalbantoğlu State Hospital, Gynecology Service. The research will be carried out experimentally, 2 experiments (massage group and acupressure group) and 1 control group will be formed. 95% confidence for the study to be performed with statistically 90% power It was calculated that 22 pregnant women should be given acupressure, 22 pregnant women should be given acupressure and 22 pregnant women should be in the control group with a 5% margin of error. sample size G*Power (Version 3.1.9.2 for Mac) software was used for calculation. Of the pregnant women to be included in the experimental groups; It is planned to be performed with women over the age of 18 and under the age of 35 who are hospitalized in the Gynecology Service of the Near East University Hospital, are at term, have a single fetus, are expected to have spontaneous delivery, do not have pregnancy complications or systemic diseases, and agree to participate in the study. With the volunteer participants who meet these conditions, the study will continue until the number of births is completed. In order to reduce the pain experienced during labor, acupressure will be applied in the first stage of labor, at the end of the latent, active and transitional phases, cervical dilation will be applied for 30 minutes at 3-4, 5-7, 8-10 cm intervals.
In the study, the Visual Analog Scale (VAS) will be used in the evaluation of labor pain. VAS; It is helpful in the broad definition of labor pain. VAS is a horizontally or vertically drawn It is a 10 cm long ruler that says no pain at one end and excruciating pain at the other end. It is thought to be the most appropriate scale among one-dimensional scales in determining the severity of pain, since it gives quick results, is easy and understandable, and is not guided by numbers. Visual Analog Scale is extremely simple, efficient, It is a pain intensity measurement method that can be repeated and requires minimal tools. The Birth Satisfaction Scale (DME) will be used to assess birth satisfaction. DME is a Likert-type scale consisting of 30 questions. The score that can be obtained from the scale varies between 30-150 points. As the score obtained from the scale increases, the satisfaction with the birth increases. VAS scores will be evaluated a total of 3 times at all these stages to assess pain. In the same way, the massage will be evaluated with the VAS score by applying it for 30 minutes in 3 phases. Finally, by making sure that the woman is resting in the postpartum period, a 30-item questionnaire was used to measure her satisfaction with her birth experience.
"Birth Satisfaction Scale" will be filled. The original "Birth Satisfaction Scale (BSS)" was developed in 2009 by Caroline Hollins. Turkish validity and reliability study was conducted by Coşar Çetin F. et al. in 2015. Responses to this 5-point Likert-type scale; Strongly Agree 5; Agree 4; I'm undecided 3; disagree 2; Strongly Disagree Scoring as 1. In scale items; 4, 8, 12, 15, 16, 17, 19, 20, 21, 23, 25 and 29 are scored as reverse items. The total number of points to be taken from the scale varies between 30 and 150 points. The sub-themes in the scale were quality of care, birth environment, adequate support.
- Conditions
- Labor Pain
- Being tested
- massage
- Keywords
- Massage, acupressure, labor pain, birth satisfaction
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageOther
Also called Acupressure
Massage and acupressure were applied when cervical dilatation was 3-4, 5-7 and 8-10 cm in latent active and transitional phases.
| Study group | Role | What they receive |
|---|---|---|
| massage | Experimental | Massage was applied to people who were hospitalized in the obstetrics ward of the pregnant woman, had a single fetus, awaiting spontaneous delivery, had no pregnancy complications, had no systemic disease, and agreed to voluntarily participate in the study. Receives: Other: massage |
| acupressure | Experimental | Acupressure for pregnant women who are hospitalized in the obstetrics service, have a single fetus, expect spontaneous delivery, do not have pregnancy complications, do not have any systemic disease, and agree to voluntarily participate in the study. Receives: Other: massage |
| control group | No intervention | No intervention was performed on the patients who were hospitalized in the obstetrics service of the pregnant woman, had a single fetus, awaiting spontaneous delivery, had no pregnancy complications, had no systemic disease, and agreed to voluntarily participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Skala-VAS
The VAS is a 10 cm long ruler drawn horizontally or vertically with the words "no pain" at one end and "unbearable pain" at the other end.
Measured: 1 year
Secondary outcomes (1)
Birth Satisfaction Scale
The Birth Satisfaction Scale is a Likert-type scale consisting of 30 questions. The score that can be obtained from the scale varies between 30-150 points.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Nov 2022
- Primary completion15 Jun 2023
- Study completion15 Jun 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.
- 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
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağla Taş, Near East University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057116
- Sponsor's protocol ID
- YDU/2022/105-1587
- Other IDs
- YDU/2022/105-1587
- Acronym
- Neu
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2023
- Last updated
- 28 Sep 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Massage and Acupressure on Labor Pain and Birth Satisfaction
- ClinicalTrials.gov ID
- NCT06057116
- Acronym / sponsor ID
- Neu / YDU/2022/105-1587
- Conditions
- Labor Pain
- Keywords
- Massage, acupressure, labor pain, birth satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 28 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.
This research was conducted in accordance with the experimental research design to determine the effect of acupuncture and massage, which are non-pharmacological methods used in the treatment of labor pain, on the latent, active and transition stages of the first stage of labor. On labor pain and birth satisfaction. Burhan Nalbantoğlu State Hospital and Near East Hospital. There are three groups in the research sample: acupuncture, massage and control groups. A total of 66 people were reached, 22 people in each group. Massage and acupuncture were applied to the intervention groups, while pregnant women in the control group were not intervened other than routine hospital practices. Cervical dilatation was applied for 3-4, 5-7 and 8-10 cm, and massage was applied for 10 minutes each, for a total of 30 minutes. When cervical dilatation was 3-4, 5-7 and 8-10 cm, acupressure was applied for 1 minute each. The pain level perceived by the pregnant woman was evaluated with the Visual Comparison Scale (VAS), and her satisfaction with the birth was evaluated with the Birth Satisfaction Scale (DME). In comparing the Birth Satisfaction Scale scores and Postpartum Pain VAS Scores, the normal distribution of the data was examined with the Kolmogorov-Smirnov test, Shapiro-Wilk test and skewness-kurtosis values and it was determined that it showed a normal distribution, ANOVA was applied. Tukey test was used in further analysis for comparisons. ANCOVA was applied to compare the amount of pain changes at the beginning and end of the latent, active and transition phases according to participant groups.
Detailed description
The research will be carried out at the Near East Hospital and Nicosia Burhan Nalbantoğlu State Hospital, Gynecology Service. The research will be carried out experimentally, 2 experiments (massage group and acupressure group) and 1 control group will be formed. 95% confidence for the study to be performed with statistically 90% power It was calculated that 22 pregnant women should be given acupressure, 22 pregnant women should be given acupressure and 22 pregnant women should be in the control group with a 5% margin of error. sample size G*Power (Version 3.1.9.2 for Mac) software was used for calculation. Of the pregnant women to be included in the experimental groups; It is planned to be performed with women over the age of 18 and under the age of 35 who are hospitalized in the Gynecology Service of the Near East University Hospital, are at term, have a single fetus, are expected to have spontaneous delivery, do not have pregnancy complications or systemic diseases, and agree to participate in the study. With the volunteer participants who meet these conditions, the study will continue until the number of births is completed. In order to reduce the pain experienced during labor, acupressure will be applied in the first stage of labor, at the end of the latent, active and transitional phases, cervical dilation will be applied for 30 minutes at 3-4, 5-7, 8-10 cm intervals.
In the study, the Visual Analog Scale (VAS) will be used in the evaluation of labor pain. VAS; It is helpful in the broad definition of labor pain. VAS is a horizontally or vertically drawn It is a 10 cm long ruler that says no pain at one end and excruciating pain at the other end. It is thought to be the most appropriate scale among one-dimensional scales in determining the severity of pain, since it gives quick results, is easy and understandable, and is not guided by numbers. Visual Analog Scale is extremely simple, efficient, It is a pain intensity measurement method that can be repeated and requires minimal tools. The Birth Satisfaction Scale (DME) will be used to assess birth satisfaction. DME is a Likert-type scale consisting of 30 questions. The score that can be obtained from the scale varies between 30-150 points. As the score obtained from the scale increases, the satisfaction with the birth increases. VAS scores will be evaluated a total of 3 times at all these stages to assess pain. In the same way, the massage will be evaluated with the VAS score by applying it for 30 minutes in 3 phases. Finally, by making sure that the woman is resting in the postpartum period, a 30-item questionnaire was used to measure her satisfaction with her birth experience.
"Birth Satisfaction Scale" will be filled. The original "Birth Satisfaction Scale (BSS)" was developed in 2009 by Caroline Hollins. Turkish validity and reliability study was conducted by Coşar Çetin F. et al. in 2015. Responses to this 5-point Likert-type scale; Strongly Agree 5; Agree 4; I'm undecided 3; disagree 2; Strongly Disagree Scoring as 1. In scale items; 4, 8, 12, 15, 16, 17, 19, 20, 21, 23, 25 and 29 are scored as reverse items. The total number of points to be taken from the scale varies between 30 and 150 points. The sub-themes in the scale were quality of care, birth environment, adequate support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| massage | Experimental | Other: massageMassage was applied to people who were hospitalized in the obstetrics ward of the pregnant woman, had a single fetus, awaiting spontaneous delivery, had no pregnancy complications, had no systemic disease, and agreed to voluntarily participate in the study. |
| acupressure | Experimental | Other: massageAcupressure for pregnant women who are hospitalized in the obstetrics service, have a single fetus, expect spontaneous delivery, do not have pregnancy complications, do not have any systemic disease, and agree to voluntarily participate in the study. |
| control group | No intervention | –No intervention was performed on the patients who were hospitalized in the obstetrics service of the pregnant woman, had a single fetus, awaiting spontaneous delivery, had no pregnancy complications, had no systemic disease, and agreed to voluntarily participate in the study. |
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 |
|---|---|---|
| massageAlso: AcupressureMassage and acupressure were applied when cervical dilatation was 3-4, 5-7 and 8-10 cm in latent active and transitional phases. | Other | acupressure, massage |
Primary outcome
Visual Analog Skala-VAS
Time frame: 1 year
The VAS is a 10 cm long ruler drawn horizontally or vertically with the words "no pain" at one end and "unbearable pain" at the other end.
1 secondary outcome
Birth Satisfaction Scale
Time frame: 1 year
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 28 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Labor Pain, run by Near East University, Turkey 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?
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 28 Sep 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 Analog Skala-VAS (time frame: 1 year). 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 28 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.