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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05729854
Other study ID # aiçu-ebe-KT-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 20, 2023
Est. completion date May 31, 2023

Study information

Verified date February 2023
Source Agri Ibrahim Cecen University
Contact Kübra TÜRKBEN
Phone +905446495489
Email kturkben@agri.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Agri Ibrahim Cecen University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 one day
Secondary 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. one day
Secondary 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. one day
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