Effects of Orally Administered Preliminary Analgesic Therapy in Diagnostic Colposcopy Patients: A Prospective Questionnaire Study

2.1. Study Population

The study was performed prospectively at the Outpatient Colposcopy Clinic of the University of Patras, during a 7-months period. Our study population consisted of 112 patients with diagnosed or suspected cervical pathology (abnormal smear, persistent cervicitis, cervical bleeding, external condylomas, etc.), which were about to undergo diagnostic colposcopy either as a first exam or as a repeat procedure. Patients with hypersensitivity to paracetamol, severe liver or renal disease, renal calculi, psychiatric or antiepileptic medica- tion, as well as pregnancy, were excluded from the study.

Patients were randomly assigned to one of the two groups, using a list of random numbers. The first group received 1gr paracetamol in pill form (interventional arm) 30 to 60 minutes before colposcopic assessment, while the other group received no medication (control group). Procedures lasted for 20 - 30 minutes and were strictly diagnostic; when biopsies were required, they were scheduled for a later appointment. One board-certified and experienced colposcopist performed all exams. Colposcopic findings, management options and future treatment plans were discussed in detail at the end of colposcopic assess- ment. Subsequently, all participating patients filled a 2-page questionnaire.

Consecutive colposcopy patients have been enrolled and no selection criteria applied during recruitment. The study has been approved by the University Hospital’s Ethics Committee (HEC no.: 5922) before recruitment commenced and was conducted in accordance with the Helsinki Declaration and the principles of good clinical practice.

2.2. Questionnaire

A questionnaire for the collection of qualitative and quantitative data had been developed for the purposes of the study, representing a combined synthesis of STAI-AD (State Trait Anxiety Inventory for Adults, for assessing anxiety) and a numeric scale for the scoring of pain (0-10 Numeric Pain Rating Scale) [7, 8]. The sequence of “closed type” questions to assess anxiety and distress had predetermined answers (Not at all, barely, moderately, very much). The specific questions posed were 1. Did you feel calm? 2. Did you feel tension? 3. Did you feel secure? 4. Did you feel comfortable? 5. Did you feel upset? 6. Did you feel frightened? 7. Did you feel satisfied? 8. Did you feel worried? As for the rating of pain, patients were asked to point the number that represented more accurately the intensity of pain they experienced during the exam: “0” accounted for “no pain at all”, and “10” accounted for the worst pain one could experience (Fig. 1).

The questionnaire was anonymized and it only required the age of the patient as inputs and whether this was the patient’s first colposcopy. A copy of the questionnaire is attached as an appendix at the end of this article.

2.3. Statistical Analysis

In statistical analyses, continuous variables are presented as mean values with range, while categorical variables are presented as the number of cases (%). Comparisons between groups were performed using one-way ANOVA (continuous variables) or Chi-square / Fisher’s exact test (categorical variables). Statistical analyses were performed using IBM SPSS statistical package v.24 (IBM Corp. Armonk, NY). A p value <0.05 was considered statistically significant.

4.1. Colposcopy and Negative Feelings

Colposcopy – related anxiety and pain represent well documented procedural issues inasmuch that the US preventive Task Force currently regards them as harms related with cervical cancer screening [9]. The physical and psychological consequences of colposcopy are interrelated, with an anticipated and justified procedural psychosomatic burden based on the remote position of the cervix, which inevitably entails a copious exam in close proximity with the physician.

The study of Bosgraaf et al. illustrated that psychological stress before colposcopy was seen as being caused both by an unsatisfactory explanation of abnormal cervical smears and the colposcopy procedure itself [10]. The authors underscored that a fear of cancer, pain and discomfort, embarrassment, waiting time in the hospital and a longer interval between referral and the actual colposcopy appointment increased psychological stress and anxiety. Anxious or depressive patients can be more nervous regarding the colposcopic procedure [11].

Even though the pain associated with colposcopy is generally minimal, this particular feeling is multifactorial and anxiety itself can precipitate the increased perception of pain and decreased pain tolerance [12, 13]. The intensity of pain is increased in interventional colposcopic procedures (biopsies, treatments) [14, 15]. Pain scores can drop significantly when colposcopy is performed by more experienced physicians [16].

Taken together, pain expectancy and anxiety fuel discom- fort diminish the acceptability of colposcopic examinations, posing difficulties in accomplishing the colposcopy procedure [17]. Additionally, this procedure-related stress might prove detrimental for compliance rates, influencing adherence negatively and increasing the risk of non-attendance in the subsequent follow-up colposcopy visits [5, 17, 18].

4.2. Possible Interventions

Despite the abundance of articles, the literature predominantly focuses on interventional colposcopy (i.e. involving biopsies or treatments); fewer published studies have assessed purely diagnostic colposcopy.

Several approaches have been so far proposed for colposcopy-related anxiety, such as allowing the patient to follow the ongoing procedure via video-colposcopy [12], relaxing music or videos with stress-relieving themes that help to distract the patients’ attention [19, 20]. Furthermore, some authors acknowledge that the provision of both sensory (i.e., how the procedure will feel) and procedural information (i.e., what exactly the procedure will involve), results in reduced anxiety, pain, and distress [21]. In this setting, leaflets and information videos have been proposed as a means to alleviate anxiety with mixed results [3, 22, 23]. The Cochrane meta-analysis [24] on colposcopy-related anxiety concludes that video colposcopy and playing music represent the most effective interventions. As for informative leaflets, the meta-analysis considers them unhelpful in diminishing anxiety, merely regarding them useful in providing procedural informed consent.

Providing women with details of the likely sensations during colposcopy counseling as well as explaining what to expect in terms of procedural steps and time may ensure expectations are appropriate and may also reduce the pain experienced during colposcopy [5, 25]. Since procedure-related pain and discomfort are closely associated, decreasing pain with medical or alternative methods would also alleviate sensations of discomfort, and ultimately prevent an unpleasant colposcopy experience [26]. Chan et al. documented beneficial effects of music in terms of significantly lower pain and less anxiety [4]. The prospective study of Carwile et al. used passive visual distraction and concluded that this approach reduced perceived pain but not overall anxiety [27].

Previous studies evaluating pain relief effectiveness of oral ibuprofen during interventional colposcopy [6] concluded that this agent provided no advantage over placebo in decreasing colposcopy pain. In their comprehensive review, Ireland et al. [25] advocate that current evidence does not support the routine use of any systemic or local anesthesia during colposcopy. In particular, oral analgesia, such as NSAIDs, topical lidocaine-prilocaine cream, or lignocaine or benzocaine sprays were found to be ineffective strategies for pain control during colposcopy [25]. Finally, the most recent Cochrane meta-analysis on colposcopy-related pain relief, focused on interventional colposcopy and illustrated limited value of oral analgesics [14].

4.3. Paracetamol and Colposcopy

Older uncontrolled studies suggested that oral nonsteroidal anti-inflammatory drugs (NSAIDs) are beneficial for colposcopy [28]. Similar to NSAIDs, paracetamol also inhibits the enzyme cyclooxygenase, however, its action is in the central nervous system rather than the periphery [29, 25]. Despite its inferiority compared to ibuprofen for control of uterine pain, paracetamol represents a valid option for women who cannot tolerate NSAIDs [25, 29].

4.4. Our Study Results

In this study, patients were prospectively recruited and all procedures have been performed by one single board-certified colposcopist. The choice of the particular pharmaceutical agent (paracetamol) was primarily based on its pharmaceutical properties (weak inhibitor of prostaglandin biosynthesis in the CNS, featuring analgesic and anti-febrile properties), its wide availability and popularity, the absence of severe untoward or side effects and low price. The design of our study mandated that pharmaceutical administrations were kept in a minimal interventional frame, avoiding drugs with anxiolytic properties. It is plausible that if other medications had been administered, then these interventions might have altered the content of answers in the questionnaires.

As was also observed by Valdini et al., the documented average scores of distress for patients experiencing their first colposcopy were higher in all aspects than those in women having repeat examinations [11].

4.5. Possible Limitations in Our Study

Potential limitations of the study might represent: i) the non-homogenous sample (first/repeat procedure); however, the groups were similar in this respect; ii) vaccination status was not documented; we have anecdotally observed less difficulties and improved co-operation with the procedure among vaccinated individuals and iii) paracetamol was administered in standard dose; it is possible that an increased dosage of paracetamol 1500mg of this medication might have a more pronounced effect and therefore yield statistically significant results [30].