Valsalva Maneuver and Control in Reducing Pain During Spinal Injection

Not Applicable

Completed

• Conditions: Brachytherapy
• Interventions: Other: Valsalva maneuver; Other: Control

• Registration Number: NCT04215276
• Lead Sponsor: Indonesia University

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 Timeline

• Study Start: 2019-01-21
• Primary Completion: 2019-04-26
• Study Completion: 2019-04-26
• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valsalva Maneuver	Valsalva maneuver	Patient will do valsalva maneuver for 20 seconds
control	Control	Patient will do nothing

Primary Outcome Measures

Name	Time	Method
Pain measurement during injection with VAS score	30 seconds	Pain degree was measured with VAS score \[0 equals to no pain whereas 10 equals to the maximum pain\]

Secondary Outcome Measures

Name	Time	Method
Patient movement	30 seconds	Investigator observes patient movement during the first spinal injection

Trial Locations

Locations (1)

Cipto Mangunkusumo National Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia