PainAcupressNCT05311449

The Effect of Post-Cesarean Section Acupressure on the Severity of Pain and First Mobilization Distance

A study testing Acupressure and Plasebo acupressure in people with Pain and Mobilization, run by Mersin University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This randomized controlled trial evaluates the effect of acupressure application on cesareans' pain and the number of steps in the first mobilization. This study hypothesizes that acupressure reduces pain and improves number of steps. 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, Mobilization
What is being tested?: Acupressure and Plasebo acupressure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 26 Jun 2022to 22 Jul 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 conscious,
The mother tongue is Turkish,
To be oriented and cooperative,
be between 18-45 years old,
To voluntarily agree to participate in the study (signing the Informed Consent Form),
Repeated cesarean section,

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Cesarean section under spinal anesthesia,
Not having a risky pregnancy (preeclampsia, gestational diabetes etc.),
No health problems of the fetus,
To have given birth by cesarean section between 37-40 weeks,
To be in the second hour of the postpartum period,
Not receiving post-op patient-controlled analgesia,
Not to have smoked or used alcohol during pregnancy,
No complications in the mother and/or newborn after cesarean section,
No sensitivity in the area where acupressure will be applied,
Absence of any systemic or psychiatric diagnosis,
Absence of active COVID-19 infection.

Who cannot join

Lack of consciousness,
The mother tongue is not Turkish,
Not oriented and cooperative,
Not to be between the ages of 18-45,
Refusal to voluntarily participate in the study (those who did not sign the Informed Consent Form),
Normal birth or cesarean delivery under general anesthesia,

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Cesarean delivery due to the risk of deterioration of maternal or fetal health,
Not having had a risky pregnancy (preeclampsia, gestational diabetes, etc.),
Not giving birth outside 37-40 weeks and by cesarean section,
Not in the second hour of the postpartum period,
Receiving post-op patient-controlled analgesia,
To have used cigarettes and alcohol during pregnancy,
Sensitivity in the area where acupressure will be applied,
Presence of any systemic or psychiatric diagnosis,
Active COVID-19 infection.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Mersin University
Mersin, Yenişehir, 33343

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Acupressure After Cesarean Section on Pain Intensity and First Mobilization Distance: A Double-Blind Randomized Controlled Study

Read the detailed description

Methods: In the study, 64 cesareans will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 32), an average of 15 minutes will be applied to the LI4 (liver), P6 (pericardium) and the Sanyinjia points on the splenic meridian (SP6) located on the inner side of the lower leg, four fingers above the ankle and behind the tibia. In the placebo acupressure group (n = 32), the points 1.5 cm away from the LI4, P6 and SP6 points (four points in total) will be applied for an average of 15 minutes. The primary outcome of the research is the effect of acupressure on the pain of cesareans. The secondary outcome of the study is to determine the effect of acupressure on the number of steps. The pain will be collected before and 1 minute, 2nd and 4th hour after acupressure and placebo acupressure administration. The number of steps will be collected 4th hour after acupressure and placebo acupressure administration.

Conditions: Pain, Mobilization
Being tested: Acupressure, Plasebo acupressure
Keywords: Post-cesarean, Acupressure, Pain, Step, Mobilization
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupressureOther
Also called Acupress
The experimental group will start with LI4 points, and continue with P6 and SP6 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.
Plasebo acupressureOther
Also called Placebo Acupress
In the control group, the application will start with the points 1.5 cm around the LI4, P6 and SP6 points. The application process will continue in the same way with acupressure group and the pressure intensity will be less.

Study groups in NCT05311449
Study group	Role	What they receive
Acupressure Group (experimental)	Experimental	The experimental group will be given acupressure. Receives: Other: Acupressure
Placebo Acupressure Group (control)	Placebo comparator	The placebo group will be given placebo acupressure. Receives: Other: Plasebo acupressure

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain evaluated using the visual analog scale
The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.
Measured: Change from before implementation and after 1 minute, 2nd and 4th hour after implementation

Secondary outcomes (1)

The number of steps using step counter (TNV 3D Pedometer (Model: PM2000, Made in China)
The number of steps in the first mobilization will be evaluated with a pedometer.
Measured: Change 4th hour after acupressure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 202222 Jul 2022

First posted5 Apr 2022
Study start26 Jun 2022
Primary completion26 Jun 2022
Study completion22 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Mersin UniversityThe 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, parallel, two-arm, randomized controlled clinical trial, double blind
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05311449
Sponsor's protocol ID: Mersin Universit
Acronym: Acupress
Status last verified: Sep 2022
First submitted: 27 Mar 2022
Last updated: 27 Sep 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chen Y, Xiang XY, Chin KHR, Gao J, Wu J, Lao L, Chen H. Acupressure for labor pain management: a systematic review and meta-analysis of randomized controlled trials. Acupunct Med. 2021 Aug;39(4):243-252. doi: 10.1177/0964528420946044. Epub 2020 Aug 18.
PubMed 32811182
Smith CA, Collins CT, Levett KM, Armour M, Dahlen HG, Tan AL, Mesgarpour B. Acupuncture or acupressure for pain management during labour. Cochrane Database Syst Rev. 2020 Feb 7;2(2):CD009232. doi: 10.1002/14651858.CD009232.pub2.
PubMed 32032444
Akgun M, Boz I. The effects of acupressure on post-cesarean pain and analgesic consumption: a randomized single-blinded placebo-controlled study. Int J Qual Health Care. 2020 Nov 16;32(9):609-617. doi: 10.1093/intqhc/mzaa107.
PubMed 32877509

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Acupressure After Cesarean Section on Pain Intensity and First Mobilization Distance: A Double-Blind Randomized Controlled Study
ClinicalTrials.gov ID: NCT05311449
Acronym / sponsor ID: Acupress / Mersin Universit
Conditions: Pain, Mobilization
Keywords: Post-cesarean, Acupressure, Pain, Step, Mobilization
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Mersin UniversityUniversity, hospital or other
Study start: 26 Jun 2022 (actual)
Primary completion: 26 Jun 2022 (actual)
Study completion: 22 Jul 2022 (actual)
First posted: 5 Apr 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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Prospective, parallel, two-arm, randomized controlled clinical trial, double blind

Arm	Type	Receives
Acupressure Group (experimental)	Experimental	Other: AcupressureThe experimental group will be given acupressure.
Placebo Acupressure Group (control)	Placebo comparator	Other: Plasebo acupressureThe placebo group will be given placebo acupressure.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (17 listed)

Being conscious,
The mother tongue is Turkish,
To be oriented and cooperative,
be between 18-45 years old,
To voluntarily agree to participate in the study (signing the Informed Consent Form),

Key exclusion criteria (15 listed)

Lack of consciousness,
The mother tongue is not Turkish,
Not oriented and cooperative,
Not to be between the ages of 18-45,
Refusal to voluntarily participate in the study (those who did not sign the Informed Consent Form),

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
AcupressureAlso: AcupressThe experimental group will start with LI4 points, and continue with P6 and SP6 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.	Other	Acupressure Group (experimental)
Plasebo acupressureAlso: Placebo AcupressIn the control group, the application will start with the points 1.5 cm around the LI4, P6 and SP6 points. The application process will continue in the same way with acupressure group and the pressure intensity will be less.	Other	Placebo Acupressure Group (control)

Primary outcome

Pain evaluated using the visual analog scale
Time frame: Change from before implementation and after 1 minute, 2nd and 4th hour after implementation
The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.

1 secondary outcome

The number of steps using step counter (TNV 3D Pedometer (Model: PM2000, Made in China)
Time frame: Change 4th hour after acupressure

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 Sep 2022.
Background: PubMed 32811182Chen Y, Xiang XY, Chin KHR, Gao J, Wu J, Lao L, Chen H. Acupressure for labor pain management: a systematic review and meta-analysis of randomized controlled trials. Acupunct Med. 2021 Aug;39(4):243-252. doi: 10.1177/0964528420946044. Epub 2020 Aug 18.
Results publication: PubMed 32032444Smith CA, Collins CT, Levett KM, Armour M, Dahlen HG, Tan AL, Mesgarpour B. Acupuncture or acupressure for pain management during labour. Cochrane Database Syst Rev. 2020 Feb 7;2(2):CD009232. doi: 10.1002/14651858.CD009232.pub2.
Results publication: PubMed 32877509Akgun M, Boz I. The effects of acupressure on post-cesarean pain and analgesic consumption: a randomized single-blinded placebo-controlled study. Int J Qual Health Care. 2020 Nov 16;32(9):609-617. doi: 10.1093/intqhc/mzaa107.
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.

Duygu VEFİKULUÇAY YILMAZ, Doctorate study director

Mersin University

Aslıhan AKSU, master principal investigator

Mersin University

Filiz DEĞİRMENCİ, master principal investigator

Mersin 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 Plasebo acupressure in people with Pain and Mobilization, run by Mersin 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 17 inclusion and 15 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 Sep 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. Some participants in this study may receive a placebo. 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?

Pain evaluated using the visual analog scale (time frame: Change from before implementation and after 1 minute, 2nd and 4th hour after implementation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05311449, which also lists 3 linked publications.

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 Sep 2022.