PainNCT01876225
Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy
A study testing Forced coughing during cervical punch biopsy in people with Pain and Anxiety, run by Carmel Medical Center at 2 sites in Israel.
Trial summary
The use of forced coughing during cervical punch biopsy may reduce pain \& discomfort associated with the procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- What is being tested?
- Forced coughing during cervical punch biopsy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesIsrael
- Study dates
- Jun 2013to Jun 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing cervical punch biopsy
Who cannot join
- Women under 18 years old
- Women currently taking prescription pain medications
- Women who consumed pain medication up to 2 hours prior to the scheduled biopsy.
- Women who refuse to take part in the study
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Carmel Medical Center
Haifa, 3436212
Efraim Siegler, MD, 972-4-8568486, hfefraimsi@clalit.org.il
Efraim . Siegler, MD
- Recruiting
Lin Medical Center
Haifa, 3515209
Efraim Siegler, MD, 972-4-8568486, hfefraimsi@clalit.org.il
Efraim . Siegler, MD
About this study
The use of forced coughing during cervical punch biopsy may reduce pain \& discomfort associated with the procedure.
Read the detailed description
Pain and anxiety are associated with many medical procedures performed in ambulatory setting. Colposcopically guided punch biopsies are a standard procedure performed in women with abnormal cervical cytology, as a part of the diagnosis and treatment selection.
Coughing is thought to provide a distraction and to cause a momentarily increase in blood pressure, reducing pain perception.
Therefore, the present study is designed to compare pain associated with cervical punch biopsy and the effect of forced coughing on pain and pain perception.
- Being tested
- Forced coughing during cervical punch biopsy
- Keywords
- cervical biopsy, forced cough, pain, VAS scale
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced coughing during cervical punch biopsyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| No coughing | No intervention | Cervical punch biopsy without forced coughing intervention |
| coughing | Experimental | Forced coughing during cervical punch biopsy Receives: Behavioral: Forced coughing during cervical punch biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain associated with cervical biopsy
Evaluating pain during cervical punch biopsy using VAS 0-10 scale.
Measured: 10 minutes
Secondary outcomes (1)
Length of cervical punch biopsy with and without cough intervention
Measurement of procedure length in minutes
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- THERE ARE NO FUNDING SOURCES TO THE STUDY.
- Responsible party
- Principal investigator, Efraim Siegler, Carmel Medical Center
- Investigators
- Efraim Siegler, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876225
- Sponsor's protocol ID
- CMC-13-0033-CTIL
- Status last verified
- Jun 2013
- First submitted
- 9 Jun 2013
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Pain and Discomfort Associated With Cervical Punch Biopsy
- ClinicalTrials.gov ID
- NCT01876225
- Acronym / sponsor ID
- CMC-13-0033-CTIL
- Keywords
- cervical biopsy, forced cough, pain, VAS scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- THERE ARE NO FUNDING SOURCES TO THE STUDY.
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 12 Jun 2013 (estimated)
- 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 use of forced coughing during cervical punch biopsy may reduce pain \& discomfort associated with the procedure.
Detailed description
Pain and anxiety are associated with many medical procedures performed in ambulatory setting. Colposcopically guided punch biopsies are a standard procedure performed in women with abnormal cervical cytology, as a part of the diagnosis and treatment selection.
Coughing is thought to provide a distraction and to cause a momentarily increase in blood pressure, reducing pain perception.
Therefore, the present study is designed to compare pain associated with cervical punch biopsy and the effect of forced coughing on pain and pain perception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No coughing | No intervention | –Cervical punch biopsy without forced coughing intervention |
| coughing | Experimental | Behavioral: Forced coughing during cervical punch biopsyForced coughing during cervical punch biopsy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women undergoing cervical punch biopsy
Key exclusion criteria (4 listed)
- Women under 18 years old
- Women currently taking prescription pain medications
- Women who consumed pain medication up to 2 hours prior to the scheduled biopsy.
- Women who refuse to take part in the study
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 |
|---|---|---|
| Forced coughing during cervical punch biopsy | Behavioural | coughing |
Primary outcome
The pain associated with cervical biopsy
Time frame: 10 minutes
Evaluating pain during cervical punch biopsy using VAS 0-10 scale.
1 secondary outcome
Length of cervical punch biopsy with and without cough intervention
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Efraim Siegler, MD principal investigator
Carmel Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forced coughing during cervical punch biopsy in people with Pain and Anxiety, run by Carmel Medical Center at 2 sites in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Efraim siegler, MD (972-4-8568486, hfefraimsi@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain associated with cervical biopsy (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2014.