Electronic continuous pain measurement versus Verbal Rating Scale in gynaecology

ISRCTN	ISRCTN15427669
DOI	https://doi.org/10.1186/ISRCTN15427669
Secondary identifying numbers	N/A

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Miss Marjoleine Louwerse
Scientific

VU University Medical Center
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Phone	+31 20 444 4444
Email	mail@marjoleinelouwerse.nl

Study information

Study design	Prospective multi-centre observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	No participant information sheet available
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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	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.
Secondary outcome measures	1. Recollection of pain perception is assessed using the Verbal Rating Scale (VRS 0-10) after two years 2. Anxiety is measured using a numerical rating scale (0-10) at baseline 3. Tolerability of the procedure is assessed post-surgery and after two years
Overall study start date	01/06/2011
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 number of participants	Number of patients included; Colposcopy: n=51, Ovum pick-up: n=27, Hysteroscopy: n=30
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

Onze Lieve Vrouwe Gasthuis (Location East)

Oosterpark 9
Amsterdam
1091 AC
Netherlands

VU University Medical Center

De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Sponsor information

VU University Medical Center
Hospital/treatment centre

De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Phone	+31 20 444 4444
Email	j.huirne@vumc.nl
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Hospital/treatment centre

VU University Medical Center

No information available

Results and Publications

Intention to publish date	31/12/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Manuscript is ready for publication. Intending first submission BJOG end of January 2017.
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)