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The Effect of Acupressure on Shoulder Pain and Breastfeeding Self-efficacy

Primary Purpose

Shoulder Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupressure ( traditional and complementary medicine)
Sponsored by
Agri Ibrahim Cecen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring cesarean, shoulder pain, acupressure, breast-feeding, Midwifery

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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and above according to the verbal category scale (SCS), Cesarean delivery by applying spinal anesthesia, who has an outdated, single and healthy newborn, 37-40 weeks of gestation, Between 18 and 45 years old, No fractures or dislocations in the shoulder, The absence of chronic pain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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    acupressure group

    control group

    Arm Description

    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 not be applied to the control group. routine midwifery care.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    January 30, 2023
    Last Updated
    February 13, 2023
    Sponsor
    Agri Ibrahim Cecen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05729854
    Brief Title
    The Effect of Acupressure on Shoulder Pain and Breastfeeding Self-efficacy
    Official Title
    The Effect of Acupressure on Shoulder Pain and Breastfeeding Self-efficacy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 20, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2023 (Anticipated)
    Study Completion Date
    May 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Agri Ibrahim Cecen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Pain
    Keywords
    cesarean, shoulder pain, acupressure, breast-feeding, Midwifery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    experimental and control group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    acupressure group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Acupressure will not be applied to the control group. routine midwifery care.
    Intervention Type
    Other
    Intervention Name(s)
    acupressure ( traditional and complementary medicine)
    Intervention Description
    Acupressure will be applied to the shoulders, hands and legs of the women in the experimental group by the researcher.
    Primary Outcome Measure Information:
    Title
    Visual Comparison Scale (Visual Analog Scale (VAS))
    Description
    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
    Time Frame
    one day
    Secondary Outcome Measure Information:
    Title
    Verbal Category Scale (SCS)
    Description
    To describe the severity of pain on the scale, there are the words (1) mild, (2) disturbing, (3) severe, (4) very severe, (5) unbearable.
    Time Frame
    one day
    Title
    BREASTFEEDING SELF-EFFICACY SCALE SHORT FORM
    Description
    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.
    Time Frame
    one day

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    patient having a cesarean section
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kübra TÜRKBEN
    Phone
    +905446495489
    Email
    kturkben@agri.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meral Kılıç
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kübra Türkben
    Organizational Affiliation
    kturkben@agri.edu.tr
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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