Shoulder PainNCT05729854
The Effect of Acupressure on Shoulder Pain and Breastfeeding Self-efficacy
A study testing acupressure ( traditional and complementary medicine) in people with Shoulder Pain, run by Agri Ibrahim Cecen University.
Trial summary
In this study, for the first time in our country, acupressure will be examined on post-cesarean shoulder pain and breastfeeding self-efficacy by using a combination of shoulder (GB21), hand (LI4) and leg (ST36) points and applying acupressure as repeated sessions. 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
- Shoulder Pain
- What is being tested?
- acupressure ( traditional and complementary medicine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2023to 31 May 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those whose pain intensity is 45 mm or more according to the Vision Analogue Scale (VAS),
- Those who are disturbing and above according to the verbal category scale (SCS),
- Cesarean delivery by applying spinal anesthesia,
- who has an outdated, single and healthy newborn,
- 37-40 weeks of gestation,
- Between 18 and 45 years old,
Show all 12Show fewer
- No fractures or dislocations in the shoulder,
- The absence of chronic pain in the shoulder,
- No history of trauma on the shoulder,
- No systemic and chronic diseases,
- No communication problems
- Women who agree to participate in the study will be sampled.
Who cannot join
- Cesarean delivery with general anesthesia
- Shoulder pain before cesarean section,
- Those who develop any complications related to the mother and the baby in the postpartum period (bleeding, hypertension, babies taken to the neonatal intensive care unit, etc.),
- Have a body mass index above 25 kg/m2,
- Have previous acupressure experience,
- Patients who consume caffeine (tea, coffee, chocolate...),
- If necessary, patients who underwent analgesia will not be included in the study.
Trial locations and contacts
No sites are listed yet.
Meral Kılıç contact
About this study
In this study, for the first time in our country, acupressure will be examined on post-cesarean shoulder pain and breastfeeding self-efficacy by using a combination of shoulder (GB21), hand (LI4) and leg (ST36) points and applying acupressure as repeated sessions.
Read the detailed description
After a cesarean delivery, pain causes patient dissatisfaction, impaired recovery, longer hospital stays, and delayed return to normal activities. The incidence of pain in the shoulder is high after surgery on the abdomen and its organs (visceral surgery). It has an incidence of 97% in thoracotomy, 71.4% in laparoscopy, and 40% in women who underwent cesarean section. Many studies in the review of shoulder pain after surgical procedures for the abdomen and its organs blame the phrenic nerve for transmission of shoulder pain and consider it a referred pain. Effective management of pain after childbirth will enable a woman to focus on early maternal duties and reduce the risk of persistent pain and depression.7 Pain interferes with babysitting and other activities of daily living. Therefore, postpartum pain management is critical to successful breastfeeding. Limited mobility after cesarean section may prevent the baby from taking an adequate position at the breast, and pain may inhibit the let-down reflex. Non-pharmacological treatments are useful because they are simple, effective and economical, reduce opioid consumption and increase patient satisfaction. Acupressure is a hand-mediated energy healing technique. Acupressure as a whole is a manually operated, needle-free, non-invasive, cost-effective and non-pharmacological healing intervention to improve patients' well-being. While the emergence of positive situations such as excitement or satisfaction increases breastfeeding self-efficacy; Negative states such as pain, fatigue, anxiety or stress reduce the perception of breastfeeding self-efficacy. Since the mother is in both the postpartum and postoperative period after the cesarean section, pain management is provided in the safest way for the mother and the baby; Supporting pharmacological treatment with non-pharmacological applications has an important place in midwifery care. This study is unique in that it is the first time in our country to examine acupressure on shoulder pain and breastfeeding self-efficacy after cesarean section by using a combination of shoulder (GB21), hand (LI4) and leg (ST36) points and applying acupressure as repeated sessions.
- Conditions
- Shoulder Pain
- Being tested
- acupressure ( traditional and complementary medicine)
- Keywords
- cesarean, shoulder pain, acupressure, breast-feeding, Midwifery
- Medical subject headings
- Shoulder Pain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressure ( traditional and complementary medicine)Other
Acupressure will be applied to the shoulders, hands and legs of the women in the experimental group by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| acupressure group | Experimental | Acupressure will be performed by the researchers of the main, hand and body parts of the women in the experimental units.In the clinic where the study will be conducted, acupressure application hours were determined considering the analgesic treatment protocol applied. Acupressure will be applied at the 18th and 24th hours postpartum. Receives: Other: acupressure ( traditional and complementary medicine) |
| control group | No intervention | Acupressure will not be applied to the control group. routine midwifery care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Comparison Scale (Visual Analog Scale (VAS))
In the evaluation of VAS, 0 mm = no pain, 100 mm refers to unbearable pain. On the scale, 0-44 mm shows mild pain, 45-74 mm shows moderate pain, and 75-100 mm shows severe pain
Measured: one day
Secondary outcomes (2)
Verbal Category Scale (SCS)
To describe the severity of pain on the scale, there are the words (1) mild, (2) disturbing, (3) severe, (4) very severe, (5) unbearable.
Measured: one day
BREASTFEEDING SELF-EFFICACY SCALE SHORT FORM
The minimum score that can be obtained from the scale is 14, the maximum score is 70, and the scale has no breakpoint. An increase in the scale score means that breastfeeding self-efficacy is high.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start20 Feb 2023 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experimental and control group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Turkben, Agri Ibrahim Cecen University
- Investigators
- Kübra Türkben, Principal investigator, kturkben@agri.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729854
- Sponsor's protocol ID
- aiçu-ebe-KT-01
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2023
- Last updated
- 15 Feb 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 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure on Shoulder Pain and Breastfeeding Self-efficacy
- ClinicalTrials.gov ID
- NCT05729854
- Acronym / sponsor ID
- aiçu-ebe-KT-01
- Conditions
- Shoulder Pain
- Keywords
- cesarean, shoulder pain, acupressure, breast-feeding, Midwifery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 15 Feb 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.
In this study, for the first time in our country, acupressure will be examined on post-cesarean shoulder pain and breastfeeding self-efficacy by using a combination of shoulder (GB21), hand (LI4) and leg (ST36) points and applying acupressure as repeated sessions.
Detailed description
After a cesarean delivery, pain causes patient dissatisfaction, impaired recovery, longer hospital stays, and delayed return to normal activities. The incidence of pain in the shoulder is high after surgery on the abdomen and its organs (visceral surgery). It has an incidence of 97% in thoracotomy, 71.4% in laparoscopy, and 40% in women who underwent cesarean section. Many studies in the review of shoulder pain after surgical procedures for the abdomen and its organs blame the phrenic nerve for transmission of shoulder pain and consider it a referred pain. Effective management of pain after childbirth will enable a woman to focus on early maternal duties and reduce the risk of persistent pain and depression.7 Pain interferes with babysitting and other activities of daily living. Therefore, postpartum pain management is critical to successful breastfeeding. Limited mobility after cesarean section may prevent the baby from taking an adequate position at the breast, and pain may inhibit the let-down reflex. Non-pharmacological treatments are useful because they are simple, effective and economical, reduce opioid consumption and increase patient satisfaction. Acupressure is a hand-mediated energy healing technique. Acupressure as a whole is a manually operated, needle-free, non-invasive, cost-effective and non-pharmacological healing intervention to improve patients' well-being. While the emergence of positive situations such as excitement or satisfaction increases breastfeeding self-efficacy; Negative states such as pain, fatigue, anxiety or stress reduce the perception of breastfeeding self-efficacy. Since the mother is in both the postpartum and postoperative period after the cesarean section, pain management is provided in the safest way for the mother and the baby; Supporting pharmacological treatment with non-pharmacological applications has an important place in midwifery care. This study is unique in that it is the first time in our country to examine acupressure on shoulder pain and breastfeeding self-efficacy after cesarean section by using a combination of shoulder (GB21), hand (LI4) and leg (ST36) points and applying acupressure as repeated sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental and control group
| Arm | Type | Receives |
|---|---|---|
| acupressure group | Experimental | Other: acupressure ( traditional and complementary medicine)Acupressure will be performed by the researchers of the main, hand and body parts of the women in the experimental units.In the clinic where the study will be conducted, acupressure application hours were determined considering the analgesic treatment protocol applied. Acupressure will be applied at the 18th and 24th hours postpartum. |
| control group | No intervention | –Acupressure will not be applied to the control group. routine midwifery care. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Those whose pain intensity is 45 mm or more according to the Vision Analogue Scale (VAS),
- Those who are disturbing and above according to the verbal category scale (SCS),
- Cesarean delivery by applying spinal anesthesia,
- who has an outdated, single and healthy newborn,
- 37-40 weeks of gestation,
Key exclusion criteria (7 listed)
- Cesarean delivery with general anesthesia
- Shoulder pain before cesarean section,
- Those who develop any complications related to the mother and the baby in the postpartum period (bleeding, hypertension, babies taken to the neonatal intensive care unit, etc.),
- Have a body mass index above 25 kg/m2,
- Have previous acupressure experience,
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 |
|---|---|---|
| acupressure ( traditional and complementary medicine)Acupressure will be applied to the shoulders, hands and legs of the women in the experimental group by the researcher. | Other | acupressure group |
Primary outcome
Visual Comparison Scale (Visual Analog Scale (VAS))
Time frame: one day
In the evaluation of VAS, 0 mm = no pain, 100 mm refers to unbearable pain. On the scale, 0-44 mm shows mild pain, 45-74 mm shows moderate pain, and 75-100 mm shows severe pain
2 secondary outcomes
Verbal Category Scale (SCS)
Time frame: one day
BREASTFEEDING SELF-EFFICACY SCALE SHORT FORM
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 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.
Meral Kılıç contact
Kübra Türkben principal investigator
kturkben@agri.edu.tr
Questions about this trial
What is this clinical trial studying?
A study testing acupressure ( traditional and complementary medicine) in people with Shoulder Pain, run by Agri Ibrahim Cecen University.
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 12 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kübra TÜRKBEN (+905446495489, kturkben@agri.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Comparison Scale (Visual Analog Scale (VAS)) (time frame: one day). 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 15 Feb 2023.