NCT00302315

Brief Summary

This study aims to investigate the effectiveness of physiotherapy applications in early postcesarean problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2006

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2006

Enrollment Period

5 months

First QC Date

March 13, 2006

Last Update Submit

March 11, 2025

Conditions

Keywords

postcesarean physiotherapyincisional painfunctional activityconnective tissue manipulationtranscutaneous electrical nerve stimulation

Outcome Measures

Primary Outcomes (4)

  • incisional pain intensity

    Intensity of incision pain was evaluated by horizontal 0-10 cm visual analogue scales (VASs:0 = no pain, 10 = unbearable pain).

    Intensity of incision pain was evaluated daily during hospitalization period before the physiotherapy program in the study group.

  • intensity of difficulty in functional activities

    Intensity of difficulty in functional activities was evaluated by horizontal 0-10 cm visual analogue scales (VASs:0 = no difficulty, 10 = unable to perform the activity).

    Intensity of difficulty in functional activities was evaluated daily during hospitalization period before the physiotherapy program in the study group.

  • first ambulation time

    Time from transfer to obstetric department room to first ambulation after cesarean.

    From transfer to obstetric department room to first ambulation after cesarean

  • onset time of bowel peristalsis

    Time of breaking gas and defecation after Cesarean.

    Only once when breaking gas and defecation occured after Cesarean.

Secondary Outcomes (2)

  • Vital signs

    Vital signs were measured before and after first ambulation

  • Length of staying at the hospital and number of analgesic/anti-inflammatory medication additional to the standard pain control procedure

    Only once before discharge from the hospital

Study Arms (1)

Routine care

ACTIVE COMPARATOR

All subjects were operated by the same obstetrician (SB) and lower segment transverse incision technique was used for the cesarean section. After delivery, patients were transferred to their rooms within the obstetric ward. Vital signs (heart rate, blood pressure and breathing rate) and body temperatures were assessed regularly. Patients were not allowed to feed orally before bowel movements had started. For post-operative pain control in the first 24 h, meperidine (50 mg, 4 × 1) and non-steroid anti-inflammatory medicine (4 × 1) were administered intravenously. If required by the patient, additional analgesics or anti-inflammatory medications were also administered by the nurses, who were blinded to the group assignment. Patients were encouraged for early ambulation after delivery if they were not hypotensive and uterine bleeding was under control. Initially, they ambulated 10-15 m inside their rooms, and the intensity increased in hours and days. Patients were usually discharged wit

Other: Physiotherapy

Interventions

Thoracic expansion exercises and huffing technique Lower limb exercises TENS with frequency of 120 Hz and pulse width of 60 μs was used for 30 min in every session Connective tissue manipulation (CTM) to the sacral and lumbar regions, Education (proper use of body mechanics during baby caring and daily activities; improving posture; anatomy and functions of the pelvic floor and Knack maneouvre)

Also known as: exercise, TENS, patient education and recommendations, connective tissue manipulation
Routine care

Eligibility Criteria

Age19 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • cesarean section giving birth to single baby having cesarean under general anesthesia

You may not qualify if:

  • giving birth to multiple babies being followed in intensive care unit after cesarean because of complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Hospital

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Physical Therapy ModalitiesExerciseTranscutaneous Electric Nerve StimulationPatient Education as Topic

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaElectric Stimulation TherapyAnalgesiaAnesthesia and AnalgesiaHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • İnci Yüksel, PT. Prof.

    Prof. PT.

    STUDY DIRECTOR
  • İlkim Çıtak Karakaya, PT. PhD.

    Research assistant

    PRINCIPAL INVESTIGATOR
  • Mehmet Gürhan Karakaya, PT. PhD.

    Research assistant

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 14, 2006

Study Start

December 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

March 13, 2025

Record last verified: 2006-03

Locations