- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05729854
The Effect of Acupressure on Shoulder Pain and Breastfeeding Self-efficacy
February 13, 2023 updated by: Kubra Turkben, Agri Ibrahim Cecen University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria
- 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,
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: acupressure group
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.
|
Acupressure will be applied to the shoulders, hands and legs of the women in the experimental group by the researcher.
|
|
No Intervention: control group
Acupressure will not be applied to the control group.
routine midwifery care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Verbal Category Scale (SCS)
Time Frame: one day
|
To describe the severity of pain on the scale, there are the words (1) mild, (2) disturbing, (3) severe, (4) very severe, (5) unbearable.
|
one day
|
|
BREASTFEEDING SELF-EFFICACY SCALE SHORT FORM
Time Frame: one day
|
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.
|
one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 20, 2023
Primary Completion (Anticipated)
May 31, 2023
Study Completion (Anticipated)
May 31, 2023
Study Registration Dates
First Submitted
January 30, 2023
First Submitted That Met QC Criteria
February 13, 2023
First Posted (Actual)
February 15, 2023
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- aiçu-ebe-KT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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