Comparison of Valsalva Maneuver and Control in Reducing Pain During Spinal Injection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indonesia University
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Pain measurement during injection with VAS score
Study Overview
Brief Summary
The study aimed to compare the effectiveness of Valsalva maneuver as non pharmacological approach and control in reducing pain during spinal injection.
Detailed Description
This was an experimental study on 70 subjects with 35 subjects treated with Valsalva maneuver and 35 subjects treated as control from January to April 2019. Research subjects were female who underwent brachytherapy for the first time with spinal anesthesia. The effectiveness in reducing pain was assessed by using Visual Analogue Scale (VAS) and patient movement during the surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients underwent elective surgery using spinal anesthesia
- •patients who have not undergone spinal anesthesia before
- •Physical status ASA I or II
- •Signing informed consent
Exclusion Criteria
- •have a spinal anesthesia history
- •contraindicated for spinal anesthesia
- •subjects who cannot do Valsalva to 30mmHg pressure for 20 seconds
- •have a allergic history to local anesthetics or opioid drugs
Outcomes
Primary Outcomes
Pain measurement during injection with VAS score
Time Frame: 30 seconds
Pain degree was measured with VAS score \[0 equals to no pain whereas 10 equals to the maximum pain\]
Secondary Outcomes
- Patient movement(30 seconds)
Investigators
Alfan Mahdi Nugroho
Principal Investigator
Indonesia University