Pain, LaborNCT05407103
Acupressure and Comfort at Childbirth
A study testing Cold Acupressure and Warm Acupressure in people with Pain, Labor, run by Serap Ozturk Altinayak at 1 site in Turkey (Türkiye).
Trial summary
Aims: Non-pharmacological methods employed for management labor pain also help pregnant women to cope with labor pain and increase their childbirth comfort. The aim of this study is to determine the effect of cold and hot acupressure applications, applied to the acupressure point LI4 of primiparous women during labor… 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
- Pain, Labor
- What is being tested?
- Cold Acupressure and Warm Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Aug 2020to 21 Feb 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 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 Applying Various Forms of Acupressure on Women's Hand During Labor on Their Childbirth Comfort: A Randomized Controlled Trial
Aims: Non-pharmacological methods employed for management labor pain also help pregnant women to cope with labor pain and increase their childbirth comfort. The aim of this study is to determine the effect of cold and hot acupressure applications, applied to the acupressure point LI4 of primiparous women during labor, on their childbirth comfort.
Methods: This study was designed a randomized controlled experimental study. The sample consisted of 129 healthy pregnant women including 44 pregnant women in the hot acupressure group, 44 pregnant women in the cold acupressure group, and 41 pregnant women in the control group. The "Personal Information Form", the "Labor Monitoring Form", the "Visual Analog Scale", and the "Childbirth Comfort Questionnaire" were all used to gather the data.
- Conditions
- Pain, Labor
- Being tested
- Cold Acupressure, Warm Acupressure
- Keywords
- Pain, Labor, Comfort
- Medical subject headings
- Labor Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold AcupressureOther
For the cold acupressure application, the researchers prepared pouches that were 3 cm long, 2 cm wide, and 1 cm high (3x2x1cm), and filled with cherry seeds - to retain heat for a longer time, hence the preference. Next, they fixed rubber bands to the pouches so that they stayed in place on the participants' hands during acupressure, and retain consistent pressure throughout. Lastly, the cold acupressure pouches were kept in a freezer for 40 minutes.
Warm AcupressureOther
For the warm acupressure application, the researchers prepared pouches that were 3 cm long, 2 cm wide, and 1 cm high (3x2x1cm), and filled with cherry seeds - to retain heat for a longer time, hence the preference. Next, they fixed rubber bands to the pouches so that they stayed in place on the participants' hands during acupressure, and retain consistent pressure throughout. Lastly, the warm acupressure pouches were heated in a microwave at 600 W for one minute.
| Study group | Role | What they receive |
|---|---|---|
| Cold Acupressure Group | Experimental | Personal information form (PIF ) , Labor Monitoring Form (LMF), Visual Analog Scale (VAS), and Childbirth Comfort Questionnaire (CCQ) as pre-test during the latent phase before going about the cold acupressure. Next, she applied the cold acupressure pouches on the respective cold group on their LI 4 point for ten minutes, during the active and transition phases. The application was then suspended for one hour, and then repeated three more times.
Last, posttest took place. Cold group was given VAS and CCQ during transition phase of dilation between contractions. The researchers then filled out LMF after cold group to monitor how they were feeling. Receives: Other: Cold Acupressure |
| Warm Acupressure Group | Experimental | PIF, LMF, VAS, and CCQ as pre-test during the latent phase before going about the warm acupressure. Next, she applied the warm acupressure pouches on the respective warm groups on their LI 4 point for ten minutes, during the active and transition phases. The application was then suspended for one hour, and then repeated three more times.
Last, posttest took place. Warm group was given VAS and CCQ during transition phase of dilation between contractions. The researchers then filled out LMF after warm group to monitor how they were feeling. Receives: Other: Warm Acupressure |
| Control Group | No intervention | The researcher ran PIF, LMF, VAS, and CCQ as pre-test during the latent phase. No intervention was applied to the control group. Last, posttest took place. Control group was given VAS and CCQ during transition phase of dilation between contractions. The researchers then filled out LMF after warm group to monitor how they were feeling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Childbirth Comfort Questionnaire (CCQ); Each item ranks between 1 and 5 points: 1=Strongly disagree, 2=Mostly disagree, 3=Partially agree, 4=Mostly agree, and 5=Completely agree. Thus, the lowest and highest scores are 9 and 45 points, respectively. The higher the score one earns, the more comfortable they are; the lower the score, the exact opposite
Measured: through study completion, an average of 1month
Secondary outcomes (1)
Labor pain
Visual Analog Scale (VAS); It is a 10-cm one-dimensional ruler; written on one end is "no pain"; on the other is "worst pain." For the purpose of this study, the researchers used VAS vertically in this study, in line with the recommendations of other studies, who suggest that individuals understand VAS better when applied vertically.
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 posted7 Jun 2022
- Study start24 Aug 2020
- Primary completion31 Mar 2021
- Study completion21 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, LaborStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serap Ozturk Altinayak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Serap Ozturk Altinayak, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407103
- Sponsor's protocol ID
- 21.05.2020-15
- Status last verified
- Jun 2022
- First submitted
- 29 May 2022
- Last updated
- 7 Jun 2022
- 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 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Applying Various Forms of Acupressure on Women's Hand During Labor on Their Childbirth Comfort: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05407103
- Acronym / sponsor ID
- 21.05.2020-15
- Conditions
- Pain, Labor
- Keywords
- Pain, Labor, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Serap Ozturk AltinayakUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 7 Jun 2022 (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.
Aims: Non-pharmacological methods employed for management labor pain also help pregnant women to cope with labor pain and increase their childbirth comfort. The aim of this study is to determine the effect of cold and hot acupressure applications, applied to the acupressure point LI4 of primiparous women during labor, on their childbirth comfort.
Methods: This study was designed a randomized controlled experimental study. The sample consisted of 129 healthy pregnant women including 44 pregnant women in the hot acupressure group, 44 pregnant women in the cold acupressure group, and 41 pregnant women in the control group. The "Personal Information Form", the "Labor Monitoring Form", the "Visual Analog Scale", and the "Childbirth Comfort Questionnaire" were all used to gather the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cold Acupressure Group | Experimental | Other: Cold AcupressurePersonal information form (PIF ) , Labor Monitoring Form (LMF), Visual Analog Scale (VAS), and Childbirth Comfort Questionnaire (CCQ) as pre-test during the latent phase before going about the cold acupressure. Next, she applied the cold acupressure pouches on the respective cold group on their LI 4 point for ten minutes, during the active and transition phases. The application was then suspended for one hour, and then repeated three more times. Last, posttest took place. Cold group was given VAS and CCQ during transition phase of dilation between contractions. The researchers then filled out LMF after cold group to monitor how they were feeling. |
| Warm Acupressure Group | Experimental | Other: Warm AcupressurePIF, LMF, VAS, and CCQ as pre-test during the latent phase before going about the warm acupressure. Next, she applied the warm acupressure pouches on the respective warm groups on their LI 4 point for ten minutes, during the active and transition phases. The application was then suspended for one hour, and then repeated three more times. Last, posttest took place. Warm group was given VAS and CCQ during transition phase of dilation between contractions. The researchers then filled out LMF after warm group to monitor how they were feeling. |
| Control Group | No intervention | –The researcher ran PIF, LMF, VAS, and CCQ as pre-test during the latent phase. No intervention was applied to the control group. Last, posttest took place. Control group was given VAS and CCQ during transition phase of dilation between contractions. The researchers then filled out LMF after warm group to monitor how they were feeling. |
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 (1 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 |
|---|---|---|
| Cold AcupressureFor the cold acupressure application, the researchers prepared pouches that were 3 cm long, 2 cm wide, and 1 cm high (3x2x1cm), and filled with cherry seeds - to retain heat for a longer time, hence the preference. Next, they fixed rubber bands to the pouches so that they stayed in place on the participants' hands during acupressure, and retain consistent pressure throughout. Lastly, the cold acupressure pouches were kept in a freezer for 40 minutes. | Other | Cold Acupressure Group |
| Warm AcupressureFor the warm acupressure application, the researchers prepared pouches that were 3 cm long, 2 cm wide, and 1 cm high (3x2x1cm), and filled with cherry seeds - to retain heat for a longer time, hence the preference. Next, they fixed rubber bands to the pouches so that they stayed in place on the participants' hands during acupressure, and retain consistent pressure throughout. Lastly, the warm acupressure pouches were heated in a microwave at 600 W for one minute. | Other | Warm Acupressure Group |
Primary outcome
Comfort
Time frame: through study completion, an average of 1month
Childbirth Comfort Questionnaire (CCQ); Each item ranks between 1 and 5 points: 1=Strongly disagree, 2=Mostly disagree, 3=Partially agree, 4=Mostly agree, and 5=Completely agree. Thus, the lowest and highest scores are 9 and 45 points, respectively. The higher the score one earns, the more comfortable they are; the lower the score, the exact opposite
1 secondary outcome
Labor pain
Time frame: through study completion, an average of 1month
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 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Pain, Labor
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.
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 Cold Acupressure and Warm Acupressure in people with Pain, Labor, run by Serap Ozturk 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 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 Jun 2022. 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?
Comfort (time frame: through study completion, an average of 1month). 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 Jun 2022.