BrachytherapyNCT04215276
Valsalva Maneuver and Control in Reducing Pain During Spinal Injection
A study testing Valsalva maneuver in people with Brachytherapy, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The study aimed to compare the effectiveness of Valsalva maneuver as non pharmacological approach and control in reducing pain during spinal injection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brachytherapy
- What is being tested?
- Valsalva maneuver
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- 21 Jan 2019to 26 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients underwent elective surgery using spinal anesthesia
- patients who have not undergone spinal anesthesia before
- Physical status ASA I or II
- Signing informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo National Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: 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.
Read the 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.
- Conditions
- Brachytherapy
- Being tested
- Valsalva maneuver, Control
- Keywords
- valsalva maneuver, control, pain, spinal injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsalva maneuverOther
pressure during Valsalva maneuver was measure using sphygmomanometer
ControlOther
patient was not given any intervention
| Study group | Role | What they receive |
|---|---|---|
| Valsalva Maneuver | Active comparator | Patient will do valsalva maneuver for 20 seconds Receives: Other: Valsalva maneuver |
| control | Placebo comparator | Patient will do nothing Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement during injection with VAS score
Pain degree was measured with VAS score [0 equals to no pain whereas 10 equals to the maximum pain]
Measured: 30 seconds
Secondary outcomes (1)
Patient movement
Investigator observes patient movement during the first spinal injection
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start21 Jan 2019
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BrachytherapyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfan Mahdi Nugroho, Universitas Indonesia
- Investigators
- Alfan M Nugroho, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215276
- Sponsor's protocol ID
- IndonesiaUAnes 048
- Status last verified
- Feb 2020
- First submitted
- 30 Dec 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calthorpe N. The history of spinal needles: getting to the point. Anaesthesia. 2004 Dec;59(12):1231-41. doi: 10.1111/j.1365-2044.2004.03976.x.
PubMed 15549987Kumar S, Gautam SK, Gupta D, Agarwal A, Dhirraj S, Khuba S. The effect of Valsalva maneuver in attenuating skin puncture pain during spinal anesthesia: a randomized controlled trial. Korean J Anesthesiol. 2016 Feb;69(1):27-31. doi: 10.4097/kjae.2016.69.1.27. Epub 2016 Jan 28.
PubMed 26885298Agarwal A, Sinha PK, Tandon M, Dhiraaj S, Singh U. Evaluating the efficacy of the valsalva maneuver on venous cannulation pain: a prospective, randomized study. Anesth Analg. 2005 Oct;101(4):1230-1232. doi: 10.1213/01.ane.0000167270.15047.49.
PubMed 16192551Cigdem UK, Sevinc S, Esef B, Sureyya O, Muzaffer G, Akif D. [A comparison of three different needles used for spinal anesthesia in terms of squamous epithelial cell transport risk]. Rev Bras Anestesiol. 2017 Sep-Oct;67(5):468-471. doi: 10.1016/j.bjan.2017.04.011. Epub 2017 May 16. Portuguese.
PubMed 28526468Pstras L, Thomaseth K, Waniewski J, Balzani I, Bellavere F. The Valsalva manoeuvre: physiology and clinical examples. Acta Physiol (Oxf). 2016 Jun;217(2):103-19. doi: 10.1111/apha.12639. Epub 2016 Jan 5.
PubMed 26662857
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Valsalva Maneuver and Control in Reducing Pain During Spinal Injection
- ClinicalTrials.gov ID
- NCT04215276
- Acronym / sponsor ID
- IndonesiaUAnes 048
- Conditions
- Brachytherapy
- Keywords
- valsalva maneuver, control, pain, spinal injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valsalva Maneuver | Active comparator | Other: Valsalva maneuverPatient will do valsalva maneuver for 20 seconds |
| control | Placebo comparator | Other: ControlPatient will do nothing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients underwent elective surgery using spinal anesthesia
- patients who have not undergone spinal anesthesia before
- Physical status ASA I or II
- Signing informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valsalva maneuverpressure during Valsalva maneuver was measure using sphygmomanometer | Other | Valsalva Maneuver |
| Controlpatient was not given any intervention | Other | control |
Primary outcome
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]
1 secondary outcome
Patient movement
Time frame: 30 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Results publication: PubMed 15549987Calthorpe N. The history of spinal needles: getting to the point. Anaesthesia. 2004 Dec;59(12):1231-41. doi: 10.1111/j.1365-2044.2004.03976.x.
- Results publication: PubMed 26885298Kumar S, Gautam SK, Gupta D, Agarwal A, Dhirraj S, Khuba S. The effect of Valsalva maneuver in attenuating skin puncture pain during spinal anesthesia: a randomized controlled trial. Korean J Anesthesiol. 2016 Feb;69(1):27-31. doi: 10.4097/kjae.2016.69.1.27. Epub 2016 Jan 28.
- Results publication: PubMed 16192551Agarwal A, Sinha PK, Tandon M, Dhiraaj S, Singh U. Evaluating the efficacy of the valsalva maneuver on venous cannulation pain: a prospective, randomized study. Anesth Analg. 2005 Oct;101(4):1230-1232. doi: 10.1213/01.ane.0000167270.15047.49.
- Results publication: PubMed 28526468Cigdem UK, Sevinc S, Esef B, Sureyya O, Muzaffer G, Akif D. [A comparison of three different needles used for spinal anesthesia in terms of squamous epithelial cell transport risk]. Rev Bras Anestesiol. 2017 Sep-Oct;67(5):468-471. doi: 10.1016/j.bjan.2017.04.011. Epub 2017 May 16. Portuguese.
- Results publication: PubMed 26662857Pstras L, Thomaseth K, Waniewski J, Balzani I, Bellavere F. The Valsalva manoeuvre: physiology and clinical examples. Acta Physiol (Oxf). 2016 Jun;217(2):103-19. doi: 10.1111/apha.12639. Epub 2016 Jan 5.
- Individual participant dataSharing planned: No
Related trials for Brachytherapy
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
Not yet recruiting
Characterizing Tumor Hypoxia With BOLD-MRI to Predict Y-90 Treatment Response
Hepatocellular Carcinoma, Liver Cancer
Active, not recruitingPhase 2
A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer
Prostate Cancer
Recruiting
Photodynamic Therapy Combined With a Self-expandable Radioactive Particle-loaded Biliary Stent for Unresectable Extrahepatic Cholangiocarcinoma
Extrahepatic Cholangiocarcinoma
Recruiting
CT- Versus MRI-Based Planning for High-Dose-Rate Prostate Brachytherapy for Prostate Cancer
Prostate Carcinoma, Stage I Prostate Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfan M Nugroho, MD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valsalva maneuver in people with Brachytherapy, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measurement during injection with VAS score (time frame: 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04215276, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.