NCT04014829 Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain After Hysterectomy
| NCT ID | NCT04014829 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KK Women's and Children's Hospital |
| Condition | Hysterectomy |
| Study Type | OBSERVATIONAL |
| Enrollment | 436 participants |
| Start Date | 2019-07-23 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 436 participants in total. It began in 2019-07-23 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase 1 (started in July 2019): Central Sensitization Inventory (CSI), Fear-Avoidance Components Scale (FACS), pain-pressure threshold are factors associated with chronic post-hysterectomy pain (CPHP), but a complete understanding on the development of CPHP is lacking. The study aims to identify clinically-relevant factors for CPHP that can be reliably assessed preoperatively. === Phase 2 (anticipated start May 2022): In addition to above factors, the association between heart rate variability (HRV) parameters, anxiety level, anticipated pain, and anticipated analgesia requirement with significant postoperative pain and CPHP will be investigated.
Eligibility Criteria
Inclusion Criteria: * Age 21 to 80 years old * American Society of Anesthesiologists Physical Scale (ASA) I to III * Benign gynaecological indications for hysterectomy * Elective abdominal or laparoscopic hysterectomy Exclusion Criteria: * Vaginal hysterectomy * Uterine prolapse, endometriosis, malignant disease, or pelvic pain as main indication for surgery * History of drug dependence or recreational drug use * History of chronic pain syndrome * Current chronic daily treatment with corticosteroids, excluding inhaled steroids * Allergy to study drugs * Major heart surgery * Heart transplant * Pacemaker inserted * Baseline non-sinus cardiac rhythm
Contact & Investigator
Farida Ithnin, MBBS
PRINCIPAL INVESTIGATOR
KK Women's and Children's Hospital
Frequently Asked Questions
Who can join the NCT04014829 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 80 Years, studying Hysterectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04014829 currently recruiting?
Yes, NCT04014829 is actively recruiting participants. Contact the research team at sng.ban.leong@singhealth.com.sg for enrollment information.
Where is the NCT04014829 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT04014829 clinical trial?
NCT04014829 is sponsored by KK Women's and Children's Hospital. The principal investigator is Farida Ithnin, MBBS at KK Women's and Children's Hospital. The trial plans to enroll 436 participants.