Topical Heat Application for Intraoperative Abortion Pain ManagementHAPPENCT02536235
Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortionl
A study testing heat in people with Topical Heat Application for Intraoperative Abortion Pain Management, run by Planned Parenthood of Greater New York at 1 site in United States.
Trial summary
Paracervical blocks are routinely used in first trimester surgical abortions and are a proven method for decreasing procedural pain. Even when paracervical anesthesia is used, an overwhelming majority of women still report at least moderate pain during a first trimester abortion procedure. Read more about this study
- Who is it for?
- Ages 16 to 51 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Topical Heat Application for Intraoperative Abortion Pain Management
- What is being tested?
- heat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jul 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 16 to 51 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Gestational age of 12 6/7 wks or less by ultrasound
- Age 16 years or older
- Requesting pregnancy termination by surgical abortion
- Eligible for outpatient pregnancy termination
- Able to provide informed consent
- English or Spanish* speaking *If research assistant hired for project is bilingual
- Electing local anesthesia only
Who cannot join
- Reports active bleeding or severe pain at time of enrollment
- Early pregnancy failure identified on pre-operative ultrasound
- Skin irritation or rash over lower abdomen
- Presumed molar pregnancy
- Possible ectopic pregnancy
- Electing intravenous sedation
- Planned intra-operative sonographic guidance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortion: A Randomized Controlled Trial
Paracervical blocks are routinely used in first trimester surgical abortions and are a proven method for decreasing procedural pain. Even when paracervical anesthesia is used, an overwhelming majority of women still report at least moderate pain during a first trimester abortion procedure. Other than some non-pharmacologic modalities (music and visualization), only the addition of intravenous medication has been shown to reduce procedural pain. Applied topical heat is effective in alleviating pain in other medical subspecialties, and in gynecology has been shown to reduce pain from dysmenorrhea, but has never been studied for intraoperative pain control during first trimester abortion.
The investigators plan to conduct a double-blinded, randomized, controlled trial investigating the utility of topical heat application as an adjunct to paracervical block in first trimester surgical abortions up to 12 6/7wks. The primary outcome is pain score, measured using VAS, at time of uterine aspiration. As secondary outcomes, the investigators will look at the effect of heat application on pain at time of speculum placement, paracervical block, tenaculum placement, cervical dilation and overall pain. Patient satisfaction will also be assessed. If found to reduce pain during abortion under local anesthesia, the use of heat could offer an inexpensive, safe and universally available adjunct to the paracervical block during this procedure.
- Being tested
- heat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heatOther
activated heating pad to lower abdomen
| Study group | Role | What they receive |
|---|---|---|
| Intervention: intraoperative topical heat | Experimental | Not described Receives: Other: heat |
| Control: no intraoperative heat | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score measured on Visual Analog Scale (VAS) at time of uterine aspiration
Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded.
Measured: collected at time of procedure.
Secondary outcomes (6)
pain score measured on VAS at time of speculum placement
Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded.
Measured: collected at time of procedure.
pain score measured on VAS at time of paracervical block
Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded.
Measured: collected at time of procedure.
pain score measured on VAS at time of tenaculum placemenet
Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded.
Measured: collected at time of procedure.
pain score measured on VAS at time of cervical dilation
Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded.
Measured: collected at time of procedure.
overall pain scores will be measured on VAS at the conclusion of the procedure
Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded at the conclusion of the procedure.
Measured: collected at conclusion of procedure.
overall satisfaction with pain management will be measured on a 5 point Likert scale
Likert scale assessing satisfaction will be based on scale from 0 to 4 where 0 equals very unsatisfied and 4 equals very satisfied.
Measured: collected at conclusion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Topical Heat Application for Intraoperative Abortion Pain ManagementStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood of Greater New York
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Principal Investigator, Principal investigator, PPNYC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536235
- Sponsor's protocol ID
- SFPRF15-20
- Acronym
- HAPPE
- Status last verified
- Sep 2016
- First submitted
- 25 Aug 2015
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applied Topical Heat as an Adjunct for Pain Control in First-Trimester Surgical Abortion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02536235
- Acronym / sponsor ID
- HAPPE / SFPRF15-20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Planned Parenthood of Greater New YorkUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 31 Aug 2015 (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.
Paracervical blocks are routinely used in first trimester surgical abortions and are a proven method for decreasing procedural pain. Even when paracervical anesthesia is used, an overwhelming majority of women still report at least moderate pain during a first trimester abortion procedure. Other than some non-pharmacologic modalities (music and visualization), only the addition of intravenous medication has been shown to reduce procedural pain. Applied topical heat is effective in alleviating pain in other medical subspecialties, and in gynecology has been shown to reduce pain from dysmenorrhea, but has never been studied for intraoperative pain control during first trimester abortion.
The investigators plan to conduct a double-blinded, randomized, controlled trial investigating the utility of topical heat application as an adjunct to paracervical block in first trimester surgical abortions up to 12 6/7wks. The primary outcome is pain score, measured using VAS, at time of uterine aspiration. As secondary outcomes, the investigators will look at the effect of heat application on pain at time of speculum placement, paracervical block, tenaculum placement, cervical dilation and overall pain. Patient satisfaction will also be assessed. If found to reduce pain during abortion under local anesthesia, the use of heat could offer an inexpensive, safe and universally available adjunct to the paracervical block during this procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: intraoperative topical heat | Experimental | Other: heat |
| Control: no intraoperative heat | No intervention | – |
Who may qualify
- Ages
- 16 to 51 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Gestational age of 12 6/7 wks or less by ultrasound
- Age 16 years or older
- Requesting pregnancy termination by surgical abortion
- Eligible for outpatient pregnancy termination
- Able to provide informed consent
Key exclusion criteria (7 listed)
- Reports active bleeding or severe pain at time of enrollment
- Early pregnancy failure identified on pre-operative ultrasound
- Skin irritation or rash over lower abdomen
- Presumed molar pregnancy
- Possible ectopic pregnancy
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 |
|---|---|---|
| heatactivated heating pad to lower abdomen | Other | Intervention: intraoperative topical heat |
Primary outcome
pain score measured on Visual Analog Scale (VAS) at time of uterine aspiration
Time frame: collected at time of procedure.
Level of pain at this step in the procedure will be recorded by patient on 100mm line where the left anchor point represents the absence of pain and the right anchor point represents the worst pain imaginable. The distance from the left anchor point to the patient's mark will be measured and recorded.
6 secondary outcomes
pain score measured on VAS at time of speculum placement
Time frame: collected at time of procedure.
pain score measured on VAS at time of paracervical block
Time frame: collected at time of procedure.
pain score measured on VAS at time of tenaculum placemenet
Time frame: collected at time of procedure.
pain score measured on VAS at time of cervical dilation
Time frame: collected at time of procedure.
overall pain scores will be measured on VAS at the conclusion of the procedure
Time frame: collected at conclusion of procedure.
overall satisfaction with pain management will be measured on a 5 point Likert scale
Time frame: collected at conclusion of procedure
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 29 Sep 2016.
- Individual participant dataSharing planned: Undecided
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.
Principal Investigator principal investigator
PPNYC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heat in people with Topical Heat Application for Intraoperative Abortion Pain Management, run by Planned Parenthood of Greater New York at 1 site in United States.
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 7 inclusion and 7 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 29 Sep 2016. 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 United States. 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?
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 score measured on Visual Analog Scale (VAS) at time of uterine aspiration (time frame: collected at time of procedure.). 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 29 Sep 2016.