Labor PainNCT04977713
Delivery Pain and Postpartum Comfort
A study testing Acupressure and Shower in people with Labor Pain and Hydrotherapy, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
In this study was aimed that acupressure applied on the BL32 point and shower application reduced the intensity of labor pain experienced by the pregnant women in the active phase of labor and increased their postpartum comfort Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Hydrotherapy, Acupressure
- What is being tested?
- Acupressure and Shower
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2019to 31 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The inclusion criteria were being 20-40 years of age;
- Having a foetus in vertex presentation
- Having a foetus weighing 2.5-4 kg, as determined through ultrasonography
- Being primiparous
- Being between 37 and 42 gestational weeks with a single foetus
- Having planned to have a spontaneous vaginal delivery
Show all 9Show fewer
- Not having used nonpharmacological pain control methods previously
- Having a cervical dilation less than 5 cm (Dabiri et al., 2014)
- Not having received analgesia or anaesthesia.
Who cannot join
- Were having a systemic disease during pregnancy (gestational diabetes, hypertension)
- Taking medication regularly
- Having a problem that prevented the woman from communicating
- Undergoing psychiatric treatment (pharmacotherapy or psychotherapy)
- Requiring an operative vaginal delivery (forceps, vacuum)
- Receiving pharmacological interventions for labour pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Acupressure and Shower Applied in the Delivery on the Intensity of Labor Pain and Postpartum Comfort
In this study was aimed that acupressure applied on the BL32 point and shower application reduced the intensity of labor pain experienced by the pregnant women in the active phase of labor and increased their postpartum comfort
Read the detailed description
Acupressure and shower are methods that can help reduce pain severity. This study thus aims to determine the effects of acupressure and shower on labour pain and postpartum comfort. This study was a randomized controlled trial (RCT). This study was the control group consisted of 40 pregnant women, while the experimental groups (acupressure and shower) consisted of 80 pregnant women in total. The experimental groups received routine labour care and either acupressure or showers upon reaching three cervical dilations (4-5, 6-7 and 8-10 cm). The control group only received routine labour care. A maternal information form (MIF), the Visual Analog Scale for Pain (VASP) and the Postpartum Comfort Questionnaire (PPCQ) were used to collect data. CONSORT checklist was used to report the current study.
- Conditions
- Labor Pain, Hydrotherapy, Acupressure, Postpartum Period
- Being tested
- Acupressure, Shower
- Keywords
- labor pain, shower, acupressure, midwife, postpartum comfort
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
A researcher sat behind the women to comfortably access the sacral area and be in the appropriate position. The researcher then applied deep rotational pressure on the BL32 points until her nail bed colour changed to prevent any discomfort in the participants
ShowerOther
During uterine contractions, these participants took a shower while standing, with a researcher on hand to assist her (average time: 20 minutes). The water's temperature was between 22°C and 26°C.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure group | Experimental | In the acupressure uterine contractions were checked before the care application began. Acupressure was applied when the women's cervical dilation reached 4-5 cm, 6-7 cm and 8-10 cm. This method was applied 18 times during uterine contractions. The application stopped at the end of each contraction and resumed once another contraction started. No application was performed between contractions. Receives: Other: Acupressure |
| Shower Group | Experimental | The shower group, uterine contractions were checked before the care application began. A shower was applied when the women's cervical dilation reached 4-5 cm, 6-7 cm and 8-10 cm. This method was applied 18 times during uterine contractions. The application stopped at the end of each contraction and resumed once another contraction started. No application was performed between contractions. Receives: Other: Shower |
| Control group | No intervention | The women in the control group underwent routine hospital care. They were administered neither pharmacological nor nonpharmacological methods to reduce labour pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce labor pain
The participants were applicated acupressure, and shower as for birth pain. Pain has been evaluated with VASP.
Measured: Evaluation was done until delivery (on average between 8-12 hours)
Postpartum comfort levels
Postpartum comfort levels of the groups who received acupressure and shower in the postpartum period were evaluated.Postpartum comfort level has been evaluated with PPCQ.
Measured: 2 hours after birth
A maternal information form
This form consisted of 13 items asking for the participants' sociodemographic characteristics
Measured: before birth
Visual Analog Scale for Pain (VASP)
This scale is a 0-10 cm ruler developed by Bond and Pilowsky (Hawker et al., 2011; Aslan and Öztürk, 2014; Kömürcü and Ergin, 2014; Bond and Pilowsky, 1996). VASP is a 10 cm ruler which assessment with "no pain" at one end and "worst pain" at the other end. A Turkish validity and reliability study of the VASP was performed by Aslan and Öztürk (Aslan and Öztürk, 2014; Kömürcü and Ergin, 2014; Aslan, 2004).
Measured: Evaluation was done until delivery (on average between 8-12 hours)
Postpartum Comfort Questionnaire (PPCQ)
The 48-item General Comfort Scale, developed by Kolcaba (Kolcaba, 1994), was first adapted into Turkish in 2008 by Kuğuoğlu and Karabacak, who also conducted a Turkish validity and reliability study on the scale (Kuğuoğlu and Karabacak, 2008). Based on the Turkish version of the GCS, Karakaplan and Yıldız (Karakaplan and Yıldız, 2010) developed the PPCQ. The PPCQ is a 5-point questionnaire with 34 items. Participants give items between 1 (strongly agree) and 5 points (strongly disagree). The lowest score possible is 34, and the highest score is 170, with higher scores indicating higher comfort levels.
Measured: 2 hours after birth
Evalution labour pain
VASP was evaluated before and after acupressure and shower applications.
Measured: Evaluation was done until delivery (on average between 8-12 hours)
Evalution postpartum comfort
Postpartum Comfort levels were evaluated in the postpartum period.
Measured: 2 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start15 May 2019
- Primary completion25 Jan 2020
- Study completion31 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Solt Kirca, Kırklareli University
- Investigators
- AYCA SOLT KIRCA, Phd, Principal investigator, Kırklareli UniversityDERYA KANZA GÜL, Md, Phd, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977713
- Sponsor's protocol ID
- KırklareliAS-4
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2021
- Last updated
- 27 Jul 2021
- 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 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acupressure and Shower Applied in the Delivery on the Intensity of Labor Pain and Postpartum Comfort
- ClinicalTrials.gov ID
- NCT04977713
- Acronym / sponsor ID
- KırklareliAS-4
- Conditions
- Labor Pain, Hydrotherapy, Acupressure, Postpartum Period
- Keywords
- labor pain, shower, acupressure, midwife, postpartum comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 25 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 27 Jul 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.
In this study was aimed that acupressure applied on the BL32 point and shower application reduced the intensity of labor pain experienced by the pregnant women in the active phase of labor and increased their postpartum comfort
Detailed description
Acupressure and shower are methods that can help reduce pain severity. This study thus aims to determine the effects of acupressure and shower on labour pain and postpartum comfort. This study was a randomized controlled trial (RCT). This study was the control group consisted of 40 pregnant women, while the experimental groups (acupressure and shower) consisted of 80 pregnant women in total. The experimental groups received routine labour care and either acupressure or showers upon reaching three cervical dilations (4-5, 6-7 and 8-10 cm). The control group only received routine labour care. A maternal information form (MIF), the Visual Analog Scale for Pain (VASP) and the Postpartum Comfort Questionnaire (PPCQ) were used to collect data. CONSORT checklist was used to report the current study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: AcupressureIn the acupressure uterine contractions were checked before the care application began. Acupressure was applied when the women's cervical dilation reached 4-5 cm, 6-7 cm and 8-10 cm. This method was applied 18 times during uterine contractions. The application stopped at the end of each contraction and resumed once another contraction started. No application was performed between contractions. |
| Shower Group | Experimental | Other: ShowerThe shower group, uterine contractions were checked before the care application began. A shower was applied when the women's cervical dilation reached 4-5 cm, 6-7 cm and 8-10 cm. This method was applied 18 times during uterine contractions. The application stopped at the end of each contraction and resumed once another contraction started. No application was performed between contractions. |
| Control group | No intervention | –The women in the control group underwent routine hospital care. They were administered neither pharmacological nor nonpharmacological methods to reduce labour pain. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The inclusion criteria were being 20-40 years of age;
- Having a foetus in vertex presentation
- Having a foetus weighing 2.5-4 kg, as determined through ultrasonography
- Being primiparous
- Being between 37 and 42 gestational weeks with a single foetus
Key exclusion criteria (6 listed)
- Were having a systemic disease during pregnancy (gestational diabetes, hypertension)
- Taking medication regularly
- Having a problem that prevented the woman from communicating
- Undergoing psychiatric treatment (pharmacotherapy or psychotherapy)
- Requiring an operative vaginal delivery (forceps, vacuum)
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 |
|---|---|---|
| AcupressureA researcher sat behind the women to comfortably access the sacral area and be in the appropriate position. The researcher then applied deep rotational pressure on the BL32 points until her nail bed colour changed to prevent any discomfort in the participants | Other | Acupressure group |
| ShowerDuring uterine contractions, these participants took a shower while standing, with a researcher on hand to assist her (average time: 20 minutes). The water's temperature was between 22°C and 26°C. | Other | Shower Group |
Primary outcome
Reduce labor pain
Time frame: Evaluation was done until delivery (on average between 8-12 hours)
The participants were applicated acupressure, and shower as for birth pain. Pain has been evaluated with VASP.
Postpartum comfort levels
Time frame: 2 hours after birth
Postpartum comfort levels of the groups who received acupressure and shower in the postpartum period were evaluated.Postpartum comfort level has been evaluated with PPCQ.
A maternal information form
Time frame: before birth
This form consisted of 13 items asking for the participants' sociodemographic characteristics
Visual Analog Scale for Pain (VASP)
Time frame: Evaluation was done until delivery (on average between 8-12 hours)
This scale is a 0-10 cm ruler developed by Bond and Pilowsky (Hawker et al., 2011; Aslan and Öztürk, 2014; Kömürcü and Ergin, 2014; Bond and Pilowsky, 1996). VASP is a 10 cm ruler which assessment with "no pain" at one end and "worst pain" at the other end. A Turkish validity and reliability study of the VASP was performed by Aslan and Öztürk (Aslan and Öztürk, 2014; Kömürcü and Ergin, 2014; Aslan, 2004).
Postpartum Comfort Questionnaire (PPCQ)
Time frame: 2 hours after birth
The 48-item General Comfort Scale, developed by Kolcaba (Kolcaba, 1994), was first adapted into Turkish in 2008 by Kuğuoğlu and Karabacak, who also conducted a Turkish validity and reliability study on the scale (Kuğuoğlu and Karabacak, 2008). Based on the Turkish version of the GCS, Karakaplan and Yıldız (Karakaplan and Yıldız, 2010) developed the PPCQ. The PPCQ is a 5-point questionnaire with 34 items. Participants give items between 1 (strongly agree) and 5 points (strongly disagree). The lowest score possible is 34, and the highest score is 170, with higher scores indicating higher comfort levels.
Evalution labour pain
Time frame: Evaluation was done until delivery (on average between 8-12 hours)
VASP was evaluated before and after acupressure and shower applications.
Evalution postpartum comfort
Time frame: 2 hours after birth
Postpartum Comfort levels were evaluated in the postpartum period.
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 2021.
- 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.
AYCA SOLT KIRCA, Phd principal investigator
Kırklareli University
DERYA KANZA GÜL, Md, Phd principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure and Shower in people with Labor Pain and Hydrotherapy, run by Kırklareli University 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 9 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 2021. 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?
Reduce labor pain (time frame: Evaluation was done until delivery (on average between 8-12 hours)). The study lists 7 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 27 Jul 2021.