Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060718) titled 'The effect of scar tissue massage on pain, tactile sensation, tissue healing, scar quality, and functional status after cesarean section surgery' on June 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - No Sponsor
Condition:
Condition - Rehabilitation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of physiotherapist-guided, tele-supervised, self-administered cesarean scar massage on scar quality, pain, tactile sensory function, functional status, and tissue healing during the early postpartum period.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants assigned to the intervention group received structured scar massage training delivered by a physiotherapist during an initial face-to-face session. During this session, participants were educated about scar tissue characteristics, and scar massage techniques were demonstrated directly on the cesarean scar and surrounding tissues. The scar massage protocol included superficial and deeper tissue mobilization techniques, consisting of circular, longitudinal, and transverse movements applied to the scar and periscar regions.
Interventions/Control_2 - Participants in the control group did not receive scar massage training or any manual therapy intervention. They were provided only with standardized daily living activity recommendations, including advice on safe bed mobility, avoidance of excessive strain on the incision site during reaching, coughing, sneezing, or lifting, maintaining proper ergonomics during breastfeeding and infant care, avoiding heavy lifting and sudden bending movements, refraining from strenuous exercise, and engaging in light walking to support recovery, prevent constipation, and reduce the risk of thromboembolic complications.
Eligibility:
Age-lower limit - 18
years-old
Gender - Female
Key inclusion criteria - Inclusion criteria were women aged 18 35 years, singleton pregnancy delivered by primary cesarean section, gestational age more 34 weeks, and being at the 6th postoperative week at the time of baseline assessment.
Key exclusion criteria - Exclusion criteria included a history of previous abdominal or pelvic surgery, postoperative wound complications (infection, dehiscence, or hematoma), diagnosed neurological or rheumatological disorders, systemic diseases known to affect wound healing (e.g., diabetes mellitus), use of analgesic or anti-inflammatory medication that could influence pain perception during the study period, and inability to participate in tele-supervised follow-up sessions.
Target Size - 20
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 01 Month 01 Day
Date of IRB - 2023 Year 03 Month 07 Day
Anticipated trial start date - 2025 Year 02 Month 01 Day
Last follow-up date - 2026 Year 01 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069466
Disclaimer: Curated by HT Syndication.