Electronic continuous pain measurement versus Verbal Rating Scale in gynaecology
| ISRCTN | ISRCTN15427669 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15427669 |
| Protocol serial number | N/A |
| Sponsor | VU University Medical Center |
| Funder | VU University Medical Center |
- Submission date
- 19/01/2017
- Registration date
- 30/01/2017
- Last edited
- 23/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Minimally invasive surgery is becoming more and more common in hospitals. These procedures are performed through tiny incisions instead of one large opening, and can greatly reduce the length of surgery and the recovery time. More and more gynaecological procedures (procedures on women’s reproductive parts) are performed in an outpatient setting thanks to the development of these minimally invasive procedures, mostly performed without the need for sedation. During the procedure, patients’ perception of pain plays a key role in how well they are able to tolerate the procedure. Pain perception is usually measured using pain scores, where participants are asked to rate their level of pain at certain timepoints, however this technique is not always accurate. Being able to effectively measure pain levels during the different parts of a procedure could therefore help better deliver pain relief which could make procedures more successful. The Continuous Pain Score Meter (CPSM) is a new electrical device which has been developed to continuously monitor pain levels throughout the operation. The aim of this study is to compare the effectiveness of this device at assessing pain, compared to standard techniques.
Who can participate?
Women aged between 18 and 80 who are scheduled to have a gynaecological procedure in an outpatient setting.
What does the study involve?
Before having their surgery, participants are asked to rate how anxious they are feeling. They then receive the surgery they have been scheduled for while they are awake. The women are given the CPSM meter and instructed about how to use it. They are then asked to express their pain throughout the procedure using the device so that their pain levels can be assessed continuously. After the surgery, they are asked to rate the average pain level they felt during the procedure using a standard verbal scale. Two years later, participants are telephoned to ask them to rate the pain felt in their surgery using a standard verbal scale from what they remember.
What are the possible benefits and risks of participating?
There are no direct benefits involved with participating. There is a risk that participants may experience discomfort whilst having their procedures performed.
Where is the study run from?
1. Onze Lieve Vrouwe Gasthuis (Netherlands)
2. VU University Medical Center (Netherlands)
When is the study starting and how long is it expected to run for?
June 2011 to January 2017
Who is funding the study?
VU University Medical Center (Netherlands)
Who is the main contact?
Miss Marjoleine Louwerse
mail@marjoleinelouwerse.nl
Contact information
Scientific
VU University Medical Center
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
| Phone | +31 20 444 4444 |
|---|---|
| mail@marjoleinelouwerse.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective multi-centre observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Electronic continuous pain measurement versus Verbal Rating Scale in gynaecology: a prospective observational cohort study |
| Study objectives | The aim of this study is to: 1. Compare pain measurement between a new electronic device, the Continuous Pain Score Meter (CPSM) and the Verbal Rating Scale (VRS) during gynaecological procedures in an outpatient setting 2. Correlate these outcomes with baseline anxiety, with scored tolerability of the procedure and with pain perception 2 years after the procedure |
| Ethics approval(s) | No ethical approval was deemed necessary for this non-WMO required study. |
| Health condition(s) or problem(s) studied | Gynaecological procedures |
| Intervention | Before the procedure, patients have their anxiety score recorded. When the patient is positioned, she receives instructions on the use of the CPSM and as a part of this instruction the meter is tested once before the start of the procedure by giving the patient a mild pressure stimulus on her hand. Then, women are asked to express their pain by controlling the CPSM during the entire procedure. Immediately after the procedure, participants are asked to express the experienced average pain during the entire procedure, using the Verbal Rating Scale (VRS). Tolerability of the procedure is also reported at this point. After a period of two years women are telephoned and asked to report the VRS and tolerability of the procedure again to determine what the effect is of recollection on pain perception. |
| Intervention type | Device |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Pain of outpatient gynecological procedure is measured using the Verbal Rating Scale (VRS 0-10) directly after a procedure versus pain measurement and using the Continuous Pain Score Meter (CPSM, CPSM-AUC, CPSM-PPS, CPSM-APS) during the procedure. |
| Key secondary outcome measure(s) |
1. Recollection of pain perception is assessed using the Verbal Rating Scale (VRS 0-10) after two years |
| Completion date | 01/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Female |
| Target sample size at registration | 108 |
| Key inclusion criteria | 1. Aged between 18-80 years 2. Scheduled for a hysteroscopy, colposcopy or ovum pick-up in an outpatient setting |
| Key exclusion criteria | 1. Inability to comprehend Dutch or English properly 2. For hysteroscopy: pregnancy or women in the luteal phase without the use of contraception, known cervical stenosis or malignancy, current Sexual Transmitted Disease (STD) or Pelvic Inflammatory Disease (PID) or contra-indications for the use of NSAIDs |
| Date of first enrolment | 01/08/2011 |
| Date of final enrolment | 30/11/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Amsterdam
1091 AC
Netherlands
Amsterdam
1081 HV
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Marjoleine Louwerse (mail@marjoleinelouwerse.nl) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
