Valsalva Maneuver and Control in Reducing Pain During Spinal Injection

February 19, 2020 updated by: Alfan Mahdi Nugroho, Indonesia University

Comparison of Valsalva Maneuver and Control in Reducing Pain During Spinal Injection

The study aimed to compare the effectiveness of Valsalva maneuver as non pharmacological approach and control in reducing pain during spinal injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Valsalva Maneuver
Patient will do valsalva maneuver for 20 seconds
Other: Valsalva maneuver
pressure during Valsalva maneuver was measure using sphygmomanometer
Placebo Comparator: control
Patient will do nothing
Other: Control
patient was not given any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
30 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient movement
Time Frame: 30 seconds
Investigator observes patient movement during the first spinal injection
30 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Alfan M Nugroho, MD, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Actual)

April 26, 2019

Study Completion (Actual)

April 26, 2019

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

December 30, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUAnes 048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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