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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00302315
Other study ID # 05.T02.102.003
Secondary ID
Status Completed
Phase N/A
First received March 13, 2006
Last updated March 13, 2006
Start date December 2004
Est. completion date May 2005

Study information

Verified date March 2006
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


Description:

This study aims to investigate the effectiveness of physiotherapy applications in early postcesarean problems which make difficulties in functional activities, and includes a physiotherapy intervention group and a control group. Physical characteristics, obstetrical and surgical histories, and systemic problems, back pain, low back pain, headache, urinary/fecal incontinence problems and bowel habit of the subjects both in pregnancy and postpartum periods are recorded. First ambulation time after cesarean, presence of syncope, related vital signs, onset time of bowel peristalsis and defecation are also recorded. Intensities of incisional pain and difficulty in performing functional activities are evaluated by daily 0-10 cm visual analogue scales (VASs). Also, intensities of back pain, low back pain, headache, bloated feeling of the abdomen, and fatigue are also evaluated by daily VASs. Physiotherapy program included breathing exercises, active joint movements of the lower limbs, posture exercises, connective tissue manipulation and transcutaneous electrical nerve stimulation.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
transcutaneous electrical nerve stimulation


Locations

Country Name City State
Turkey Hacettepe University Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary incisional pain intensity
Primary intensity of difficulty in functional activities
Primary first ambulation time
Primary onset time of bowel peristalsis
Secondary vital signs before and after first ambulation
Secondary first defecation time
Secondary intensity of fatigue
Secondary number of postcesarean analgesic drug intervention
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