Postpartum DisorderNCT06138288
Acupressure Applied After Cesarean Section on Postpartum Pain
An observational study of Postpartum Disorder and Cesarean Section Complications, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Pressure applied according to the principles of acupressure limits the pain limit, reduces the secretion of endorphins, which is a neurochemical, reduces the tension in the muscles, reduces the amount of oxygen in the blood flow, and finally provides duration and relaxation. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Disorder, Cesarean Section Complications
- What is being tested?
- acupressure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteCyprus
- Study dates
- 20 Nov 2023to 30 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 18-49 age women
Who may be able to join
- agreeing to participate in the research,
- be between the ages of 18-49,
- To give birth by cesarean section between 37-40 weeks,
- Having a healthy and live birth at the end of a single pregnancy,
- Receiving spinal anesthesia
- Being able to read and write Turkish and be open to communication.
Who cannot join
- Absence of pain in the 2nd hour postpartum
- Having a cesarean delivery after a risky pregnancy,
- Having a chronic illness
- Having severe systemic disease
- Not receiving spinal anesthesia
- Having a body mass index over 25,
- Have previous acupressure experience.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupressure Applied After Cesarean Section on Postpartum Pain and Postpartum Comfort: A Randomized Controlled Study
Pressure applied according to the principles of acupressure limits the pain limit, reduces the secretion of endorphins, which is a neurochemical, reduces the tension in the muscles, reduces the amount of oxygen in the blood flow, and finally provides duration and relaxation. Acupressure application is becoming more and more common nowadays because it is a noninvasive, safe, easy-to-apply and effective method without side effects. It seems that there is a limit to the study in which group acupressure applications in the literature are examined together on pain and comfort after cesarean section. In these basic points, the expectations of achieving postpartum pain and postpartum comfort of acupressure applied after cesarean delivery in this study. The circle of the research; There will be women who will have repeated cesarean section in a private Obstetrics Clinic in Famagusta. Women will be separated from two groups, one group will continue acupressure and the other group will do routine care. Visual analog scale and end-of-birth comfort procedure will be applied to women before and after the application.
Read the detailed description
Pressure applied according to the principles of acupressure limits the pain limit, reduces the secretion of endorphins, which is a neurochemical, reduces the tension in the muscles, reduces the amount of oxygen in the blood flow, and finally provides duration and relaxation. Acupressure application is becoming more and more common nowadays because it is a noninvasive, safe, easy-to-apply and effective method without side effects. It seems that there is a limit to the study in which group acupressure applications in the literature are examined together on pain and comfort after cesarean section. In these basic points, the expectations of achieving postpartum pain and postpartum comfort of acupressure applied after cesarean delivery in this study. The circle of the research; There will be women who will have repeated cesarean section in a private Obstetrics Clinic in Famagusta. Women will be separated from two groups, one group will continue acupressure and the other group will do routine care. Visual analog scale and end-of-birth comfort procedure will be applied to women before and after the application.
- Being tested
- acupressure
- Keywords
- cesarean section, acupressure, postpartum, pain, postpartum comfort
- Medical subject headings
- Puerperal Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureBehavioural
The acupressure points to be used in the research are located on the inner side of the lower leg, 4 fingers above the ankle and on the spleen meridian behind the tibia (SP6), which was previously effective in reducing pain, and located three fingers above the wrist (in the middle of the 2nd metacarpal bone, on the dorsum of the hand, adjacent The points determined as P6 (located between the metacarpal bones) and LI4 located in the space between the thumb and index finger (between the 1st and 2nd metacarpal bones of the hand, in the middle of the 2nd metacarpal bone on the radial side) were applied by a certified researcher to women in the acupressure group. will be done
| Study group | Role | What they receive |
|---|---|---|
| acupressure group | Women who are in acupressure will apply the application after cesarean section 2nd hour after applying the data collection forms (descriptive features formula, VAS, WHO). For women on acupressure, the application will be applied manually to the SP6, P6 and L14 points in the order indicated by the drawing with the index or middle finger, 1-1.5 cm depth for 5 seconds, pressing for 5 seconds, resting for 2 seconds and continuing for 2 minutes to go. will be with you. VAS will be filled again after the application. Receives: Behavioral: acupressure | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
VAS has been developed to convert some values that cannot be measured numerically into numeric values. The VAS, which is a generally accepted, safe and easily applicable measurement tool in the world literature, consists of a 10 cm long line and there are subjective descriptive statements at both ends of the scale (0 cm = no pain and 10 cm = unbearable pain). The individual marks the appropriate place for his/her pain on this 10 cm line on the scale. The distance from the beginning of the scale to the point where the individual marks is measured with a ruler, and the pain intensity of the individual is determined numerically in cm. A low score obtained from the VAS indicates that the individual's pain intensity is low/low, and a high score indicates high/severe. The VAS is sensitive to pharmacological and non-pharmacological modalities that alter the pain experience.
Measured: 5 minutes
Secondary outcomes (1)
postpartum comfort scale
It was developed by Karakaplan and Yıldız (2010) to determine postpartum comfort. The scale is likert type and consists of 34 items. Each item is scored between "strongly agree" (5 points), and "strongly disagree" (1 point). I totally agree with positive sentences shows the best comfort (5 points), and negative sentences show low comfort (1 point). Accordingly, the lowest score to be taken from the scale is 34, and the highest score is 170. The scale has three sub-dimensions as "physical, psychospiritual and sociocultural". An increase in the score obtained from the scale indicates an increase in comfort. The Cronbach Alpha reliability of the scale was found to be .78 for the total DSQ.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Nov 2023
- Primary completion20 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Begüm Çayır, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138288
- Sponsor's protocol ID
- ETK00-2023-0107
- Status last verified
- Jan 2024
- First submitted
- 19 Jul 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cayir HB, Abic A. The effect of acupressure on postpartum pain and comfort after cesarean delivery: a randomized controlled trial. Women Health. 2024 Nov-Dec;64(10):892-903. doi: 10.1080/03630242.2024.2428793. Epub 2024 Nov 12.
PubMed 39532534
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure Applied After Cesarean Section on Postpartum Pain and Postpartum Comfort: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06138288
- Acronym / sponsor ID
- ETK00-2023-0107
- Keywords
- cesarean section, acupressure, postpartum, pain, postpartum comfort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 18 Nov 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.
Pressure applied according to the principles of acupressure limits the pain limit, reduces the secretion of endorphins, which is a neurochemical, reduces the tension in the muscles, reduces the amount of oxygen in the blood flow, and finally provides duration and relaxation. Acupressure application is becoming more and more common nowadays because it is a noninvasive, safe, easy-to-apply and effective method without side effects. It seems that there is a limit to the study in which group acupressure applications in the literature are examined together on pain and comfort after cesarean section. In these basic points, the expectations of achieving postpartum pain and postpartum comfort of acupressure applied after cesarean delivery in this study. The circle of the research; There will be women who will have repeated cesarean section in a private Obstetrics Clinic in Famagusta. Women will be separated from two groups, one group will continue acupressure and the other group will do routine care. Visual analog scale and end-of-birth comfort procedure will be applied to women before and after the application.
Detailed description
Pressure applied according to the principles of acupressure limits the pain limit, reduces the secretion of endorphins, which is a neurochemical, reduces the tension in the muscles, reduces the amount of oxygen in the blood flow, and finally provides duration and relaxation. Acupressure application is becoming more and more common nowadays because it is a noninvasive, safe, easy-to-apply and effective method without side effects. It seems that there is a limit to the study in which group acupressure applications in the literature are examined together on pain and comfort after cesarean section. In these basic points, the expectations of achieving postpartum pain and postpartum comfort of acupressure applied after cesarean delivery in this study. The circle of the research; There will be women who will have repeated cesarean section in a private Obstetrics Clinic in Famagusta. Women will be separated from two groups, one group will continue acupressure and the other group will do routine care. Visual analog scale and end-of-birth comfort procedure will be applied to women before and after the application.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupressure group | – | Behavioral: acupressureWomen who are in acupressure will apply the application after cesarean section 2nd hour after applying the data collection forms (descriptive features formula, VAS, WHO). For women on acupressure, the application will be applied manually to the SP6, P6 and L14 points in the order indicated by the drawing with the index or middle finger, 1-1.5 cm depth for 5 seconds, pressing for 5 seconds, resting for 2 seconds and continuing for 2 minutes to go. will be with you. VAS will be filled again after the application. |
| control group | – | – |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 18-49 age women
Key inclusion criteria (6 listed)
- agreeing to participate in the research,
- be between the ages of 18-49,
- To give birth by cesarean section between 37-40 weeks,
- Having a healthy and live birth at the end of a single pregnancy,
- Receiving spinal anesthesia
Key exclusion criteria (7 listed)
- Absence of pain in the 2nd hour postpartum
- Having a cesarean delivery after a risky pregnancy,
- Having a chronic illness
- Having severe systemic disease
- Not receiving spinal anesthesia
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 |
|---|---|---|
| acupressureThe acupressure points to be used in the research are located on the inner side of the lower leg, 4 fingers above the ankle and on the spleen meridian behind the tibia (SP6), which was previously effective in reducing pain, and located three fingers above the wrist (in the middle of the 2nd metacarpal bone, on the dorsum of the hand, adjacent The points determined as P6 (located between the metacarpal bones) and LI4 located in the space between the thumb and index finger (between the 1st and 2nd metacarpal bones of the hand, in the middle of the 2nd metacarpal bone on the radial side) were applied by a certified researcher to women in the acupressure group. will be done | Behavioural | acupressure group |
Primary outcome
visual analog scale
Time frame: 5 minutes
VAS has been developed to convert some values that cannot be measured numerically into numeric values. The VAS, which is a generally accepted, safe and easily applicable measurement tool in the world literature, consists of a 10 cm long line and there are subjective descriptive statements at both ends of the scale (0 cm = no pain and 10 cm = unbearable pain). The individual marks the appropriate place for his/her pain on this 10 cm line on the scale. The distance from the beginning of the scale to the point where the individual marks is measured with a ruler, and the pain intensity of the individual is determined numerically in cm. A low score obtained from the VAS indicates that the individual's pain intensity is low/low, and a high score indicates high/severe. The VAS is sensitive to pharmacological and non-pharmacological modalities that alter the pain experience.
1 secondary outcome
postpartum comfort scale
Time frame: 15 minutes
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 9 Jan 2024.
- Derived from this study: PubMed 39532534Cayir HB, Abic A. The effect of acupressure on postpartum pain and comfort after cesarean delivery: a randomized controlled trial. Women Health. 2024 Nov-Dec;64(10):892-903. doi: 10.1080/03630242.2024.2428793. Epub 2024 Nov 12.
- 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?
An observational study of Postpartum Disorder and Cesarean Section Complications, run by Eastern Mediterranean University at 1 site in Cyprus.
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 6 inclusion and 7 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 9 Jan 2024. 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 Cyprus. 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 scale (time frame: 5 minutes). 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 NCT06138288, which also lists 1 linked publication.
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 9 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.