NCT05729854

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

January 30, 2023

Last Update Submit

February 13, 2023

Conditions

Shoulder Pain

Keywords

cesareanshoulder painacupressurebreast-feedingMidwifery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Verbal Category Scale (SCS)

    one day

  • BREASTFEEDING SELF-EFFICACY SCALE SHORT FORM

    one day

Study Arms (2)

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.

Other: acupressure ( traditional and complementary medicine)

control group

NO INTERVENTION

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

Interventions

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.

acupressure group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspatient having a cesarean section
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder PainBreast Feeding

Interventions

AcupressureComplementary Therapies

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Kübra Türkben

    kturkben@agri.edu.tr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kübra TÜRKBEN

CONTACT

+905446495489kturkben@agri.edu.tr

Meral Kılıç

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: experimental and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 15, 2023

Study Start

February 20, 2023

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share