Cesarean SectionNCT00302315
Effectiveness of Physiotherapy on Postcesarean Pain and Functional Activities
A study testing Physiotherapy in people with Cesarean Section, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effectiveness of physiotherapy applications in early postcesarean problems. Read more about this study
- Who is it for?
- Ages 19 to 42 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Physiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2004to May 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- cesarean section giving birth to single baby having cesarean under general anesthesia
Who cannot join
- giving birth to multiple babies being followed in intensive care unit after cesarean because of complications
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the effectiveness of physiotherapy applications in early postcesarean problems.
Read the detailed 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.
- Conditions
- Cesarean Section
- Being tested
- Physiotherapy
- Keywords
- postcesarean physiotherapy, incisional pain, functional activity, connective tissue manipulation, transcutaneous electrical nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Also called exercise, TENS, patient education and recommendations, connective tissue manipulation
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incisional pain intensity
Intensity of incision pain was evaluated by horizontal 0-10 cm visual analogue scales (VASs:0 = no pain, 10 = unbearable pain).
Measured: 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).
Measured: 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.
Measured: From transfer to obstetric department room to first ambulation after cesarean
onset time of bowel peristalsis
Time of breaking gas and defecation after Cesarean.
Measured: Only once when breaking gas and defecation occured after Cesarean.
Secondary outcomes (2)
Vital signs
Heart rate, blood pressure, breathing rate and body temperature
Measured: 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
Length of staying at the hospital and number of analgesic/anti-inflammatory medication additional to the standard pain control procedure were recorded, and also cases were observed for any adverse effects which may be due to the physiotherapy applications.
Measured: Only once before discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startDec 2004
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlkim Çıtak Karakaya, Hacettepe University
- Investigators
- İnci Yüksel, PT. Prof., Study director, Prof. PT.İlkim Çıtak Karakaya, PT. PhD., Principal investigator, Research assistantMehmet Gürhan Karakaya, PT. PhD., Study chair, Research assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302315
- Sponsor's protocol ID
- 05.T02.102.003
- Status last verified
- Mar 2006
- First submitted
- 13 Mar 2006
- Last updated
- 13 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physiotherapy on Postcesarean Pain and Functional Activities
- ClinicalTrials.gov ID
- NCT00302315
- Acronym / sponsor ID
- 05.T02.102.003
- Conditions
- Cesarean Section
- Keywords
- postcesarean physiotherapy, incisional pain, functional activity, connective tissue manipulation, transcutaneous electrical nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 14 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effectiveness of physiotherapy applications in early postcesarean problems.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine care | Active comparator | Other: PhysiotherapyAll 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 |
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- cesarean section giving birth to single baby having cesarean under general anesthesia
Key exclusion criteria (1 listed)
- giving birth to multiple babies being followed in intensive care unit after cesarean because of complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyAlso: exercise, TENS, patient education and recommendations, connective tissue manipulationThoracic 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) | Other | Routine care |
Primary outcome
incisional pain intensity
Time frame: Intensity of incision pain was evaluated daily during hospitalization period before the physiotherapy program in the study group.
Intensity of incision pain was evaluated by horizontal 0-10 cm visual analogue scales (VASs:0 = no pain, 10 = unbearable pain).
intensity of difficulty in functional activities
Time frame: Intensity of difficulty in functional activities was evaluated daily during hospitalization period before the physiotherapy program in the study group.
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).
first ambulation time
Time frame: From transfer to obstetric department room to first ambulation after cesarean
Time from transfer to obstetric department room to first ambulation after cesarean.
onset time of bowel peristalsis
Time frame: Only once when breaking gas and defecation occured after Cesarean.
Time of breaking gas and defecation after Cesarean.
2 secondary outcomes
Vital signs
Time frame: 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
Time frame: Only once before discharge from the hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İnci Yüksel, PT. Prof. study director
Prof. PT.
İlkim Çıtak Karakaya, PT. PhD. principal investigator
Research assistant
Mehmet Gürhan Karakaya, PT. PhD. study chair
Research assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Cesarean Section, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incisional pain intensity (time frame: Intensity of incision pain was evaluated daily during hospitalization period before the physiotherapy program in the study group.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.