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Women undergoing pelvic examination for cervical cancer screening can experience periprocedural anxiety.
The aim of this study was to assess the anxiety level experienced by women undergoing a visual inspection with acetic acid and Lugol iodine (VIA and VILI) examination, with or without watching the procedure on a digital screen.
This prospective randomized study took place in the district of Dschang, Cameroon. A previous cervical cancer screening campaign tested women aged between 30 and 49 years for human papillomavirus (HPV). HPV-positive women were invited for the 12-month follow-up control visit, including a VIA/VILI examination. During that visit, we recruited women to participate in this study. Before the examination, participants were randomized in a 1:1 ratio to a control group (CG) and an intervention group (IG). Women in both groups underwent a pelvic examination and were verbally informed about the steps undertaken during the gynecological examination. The IG could also watch it live on a tablet screen. Women’s anxiety was assessed before and immediately after the examination, using the Spielberger State-Trait Anxiety Inventory (STAI). A paired
A total of 122 women were randomized in the study; 4 of them were excluded as they did not undergo the pelvic examination, did not answer to the second STAI questionnaire because of personal reasons, or the cervix could not be properly visualized. Thus, the final sample size consisted of 118 patients of whom 58 women were assigned to the CG and 60 to the IG. The mean age was 39.1 (SD 5.2) years. Before the examination, the mean (SD) STAI score was 33.6 (SD 10.9) in the CG and 36.4 (SD 11.8) in the IG (
Watching the VIA/VILI procedure in real time improved the women’s emotional state but did not reduce the periprocedural anxiety measured by the STAI score. Furthermore, larger studies should assess women’s satisfaction with watching their pelvic examination in real time to determine whether this tool could be included in VIA/VILI routine practice.
ClinicalTrials.gov NCT02945111; http://clinicaltrials.gov/ct2/show/NCT02945111
Persistent human papillomavirus (HPV) infection is a major factor of cervical cancer (CC), which is the leading cause of cancer- related death in women in South Africa [
Evidence supports that women undergoing pelvic examination can experience anxiety. This distressful feeling can be experienced before the examination (especially when it follows a pathological screening test result), during the examination, and up to several weeks after it [
As low compliance is a major barrier limiting the screening programs’ effectiveness, interventions were proposed to reduce the examination-related anxiety [
The aim of this study was to assess the anxiety level experienced by women undergoing a gynecological examination for VIA and visual inspection with Lugol iodine (VILI) while watching the procedure on a digital screen and to compare it with that of women who underwent the examination with no visual support.
This prospective randomized study took place in September 2016 in the district of Dschang. Dschang is a city located in the West Province of Cameroon, with an estimated 200,000 inhabitants. A CC screening campaign was previously carried out in the Hospital of the District of Dschang in collaboration with the Geneva University Hospitals between July and October 2015, recruiting women aged between 30 and 49 years, living in Dschang and its surroundings. HPV-positive participants were invited for a 6- and 12-month follow-up visit to assess the disease status, and participants at the 12-month visit were invited to participate in this substudy. An inclusion protocol has already been previously reported [
Participants were thoroughly informed about the study and gave their written informed consent before participation. Enrolled participants were randomized in a 1:1 ratio into 2 groups: control group (CG) and intervention group (IG).
Enrolled participants, as a part of the follow-up visit, underwent a VIA and VILI examination, during which the physician took a cervical sample for cytology and HPV testing. Women in the CG underwent routine pelvic examination as described above. They were verbally informed about the steps undertaken during the examination. Women in the IG were given verbal information about the gynecological examination while they underwent the pelvic examination and also while watching it live on a tablet screen. With the help of the local study investigators, all women filled out a validated questionnaire to determine their anxiety level both before and after the pelvic examination. To avoid potential bias before the examination and the participants’ randomization, the tablet was placed on a table when it was not being used and picked up by the examiner only at the time of the pelvic examination for patients in the IG.
In the IG, the examiners took a picture of each step of the pelvic examination with a mobile phone camera (Samsung Galaxy S3, Samsung). This device, which was chosen for its high-quality camera (16 megapixels with autofocus and flash functions), allows highly precise and detailed visualization of the cervix after zooming and focusing in on the target. Photographs were obtained at a distance of 10 to 15 cm from the cervix, with 3.3 to 3.8x optical zoom in the flash mode. The smartphone was fixed on a tripod to improve the stability and quality of the images. The images were transmitted directly from the smartphone to the tablet, a Samsung Galaxy Tab (Samsung), using Bluetooth and a specifically designed app that enabled simultaneous communication between the 2 devices. Thus, women in this group could watch the pictures taken throughout the examination in real time. Image viewing was accompanied by the clinicians’ explanations on the anatomy (ectropion, dysplasia, nulliparous cervix, and multiparous cervix) and the procedure (with an interpretation of the VIA/VILI assessment).
The anxiety was measured by asking participants in the two groups to complete the Spielberger State-Trait Anxiety Inventory (STAI) both before and immediately after the pelvic examination. The STAI is a standardized questionnaire created by Spielberger in 1983, broadly used and validated in psychology and in many medical fields [
A Web-based statistical software [
A secured, electronic medical chart using the secuTrial database (interActive Systems GmbH) including the sociodemographic and medical information (HPV test, VIA/VILI results, and cervical images) was created to register and retrieve the participants’ data.
Data were analyzed with the use of a statistical software package (Stata statistical software, release 14, StataCorp). Analyses were conducted according to the per-protocol principle. The paired
This study took place in September 2016. A total of 122 women were included in the study; of these, 4 were excluded after having been randomized. The reasons for exclusion were as follows: 3 women did not undergo the pelvic examination or did not answer to the second STAI questionnaire because of personal reasons and 1 woman was excluded because the cervix could not be properly visualized during the pelvic examination. The final sample size thus consisted of 118 patients, of which 58 women were assigned to the CG and 60 to the IG (the study design is reported in
The mean (SD) age of the participants was 39.1 (SD 5.2) years. A total of 38 out of 58 (65%) women and 40 out of 60 (67%) women had part- or full-time employment in the CG and in the IG, respectively. As women were randomized, the 2 groups did not differ with regard to sociodemographic and clinical characteristics. Participants’ characteristics are summarized in
Flow chart. CG: control group; IG: intervention group; VIA: visual inspection with acetic acid; VILI: visual inspection with Lugol iodine.
Before the examination, the mean (SD) STAI score was 33.6 (SD 10.9) in the CG and 36.4 (SD 11.8) in the IG (
Overall, the difference of the STAI scores before and after the pelvic examination was higher in the IG (7.9 [SD 14.3]) than in the CG (4.2 [SD 9.0]), although the difference was not significant (
We found that women in both groups were less anxious if they had not been treated with thermocoagulation (
Sociodemographic and clinical characteristics of the study population
Variable | Control group (n=58) | Intervention group (n=60) | ||||
Age (years) | 39.7 (5.2) | 38.4 (5.2) | ||||
Paritya | 3.8 (1.9) | 4.3 (1.8) | ||||
Single | 3 (5) | 4 (7) | ||||
With a partner | 55 (95) | 56 (93) | ||||
None | 11 (19) | 1 (2) | ||||
Elementary school | 1 (2) | 11 (18) | ||||
Apprenticeship | 33 (56) | 3 (5) | ||||
High school | 13 (22) | 38 (63) | ||||
University | —b | 7 (12) | ||||
Employed | 38 (65) | 40 (67) | ||||
Farmer | 2 (3) | 4 (7) | ||||
Housewife | 15 (26) | 13 (22) | ||||
Other | 3 (5) | 3 (5) | ||||
Negative | 41 (71) | 36 (60) | ||||
HPV-16 | — | 2 (3) | ||||
HPV-18/45 | 4 (7) | 3 (5) | ||||
Other hrHPVe | 12 (21) | 19 (32) |
a Parity: number of pregnancies ended at a viable gestational age.
bAbsence of corresponding data.
cHPV: human papillomavirus.
dThere was one missing value in the control group’s human papillomavirus test results.
ehrHPV: high-risk human papillomavirus.
Mean Spielberger State-Trait Anxiety Inventory scores in each study group.
Study question | Control group (n=58), mean (SD) | Intervention group (n=60), mean (SD) | ||||
Before pelvic examination | After pelvic examination | Before pelvic examination | After pelvic examination | |||
1. I feel calm | 1.7 (0.9) | 1.7 (1.0) | .90 | 2.1 (1.0) | 1.3 (0.8) | <.001 |
2. I feel secure | 1.7 (0.9) | 1.6 (1.0) | .62 | 2.1 (1.0) | 1.5 (1.0) | <.001 |
3. I feel tense | 1.5 (0.8) | 1.3 (0.7) | .29 | 1.9 (1.0) | 1.4 (0.9) | .002 |
4. I feel strained | 1.4 (0.8) | 1.2 (0.6) | .16 | 1.9 (1.0) | 1.2 (0.7) | <.001 |
5. I feel at ease | 1.7 (1.0) | 1.4 (0.8) | .008 | 1.9 (1.0) | 1.5 (1.0) | .03 |
6. I feel upset | 1.7 (1.0) | 1.3 (0.7) | .005 | 1.9 (1.0) | 1.5 (1.0) | .02 |
7. I am presently worrying over possible misfortunes | 1.6 (0.9) | 1.3 (0.8) | .03 | 1.7 (1.0) | 1.5 (1.1) | .23 |
8. I feel satisfied | 1.8 (1.0) | 1.6 (1.0) | .12 | 1.7 (1.0) | 1.5 (1.0) | .15 |
9. I feel frightened | 1.5 (0.9) | 1.5 (0.9) | .74 | 1.7 (1.1) | 1.6 (1.0) | .25 |
10. I feel uncomfortable | 2.1 (1.3) | 1.5 (1.0) | .002 | 1.9 (1.1) | 1.4 (1.0) | .01 |
11. I feel self-confident | 1.6 (0.9) | 1.3 (0.8) | .08 | 1.7 (0.9) | 1.4 (0.9) | .07 |
12. I feel nervous | 1.4 (0.8) | 1.2 (0.6) | .06 | 1.6 (0.9) | 1.4 (1.0) | .27 |
13. I feel jittery | 1.6 (0.9) | 1.4 (0.9) | .09 | 1.7 (1.1) | 1.4 (0.9) | .02 |
14. I feel indecisive | 1.6 (0.9) | 1.4 (0.8) | .12 | 1.7 (1.0) | 1.3 (0.8) | .004 |
15. I am relaxed | 1.8 (1.1) | 1.6 (1.0) | .27 | 2.0 (1.0) | 1.6 (1.1) | .03 |
16. I feel content | 2.0 (1.1) | 1.6 (1.0) | .002 | 1.7 (1.1) | 1.4 (1.0) | .04 |
17. I am worried | 1.9 (1.0) | 1.5 (0.8) | .004 | 1.8 (1.0) | 1.5 (1.0) | .10 |
18. I feel confused | 1.6 (0.9) | 1.3 (0.6) | .03 | 1.6 (0.9) | 1.1 (0.5) | <.001 |
19. I feel steady | 2.2 (1.0) | 2.1 (1.1) | .46 | 2.1 (1.0) | 1.6 (1.0) | .001 |
20. I feel pleasant | 1.4 (0.8) | 1.4 (0.9) | .47 | 1.8 (1.0) | 1.6 (1.0) | .37 |
Total Spielberger State-Trait Anxiety Inventory score | 33.6 (10.9) | 29.3 (11.2) | .001 | 36.4 (11.8) | 28.5 (12.0) | <.001 |
Box plot comparing anxiety between the control group and the intervention group. STAI: Spielberger State-Trait Anxiety Inventory.
Difference in Spielberger State-Trait Anxiety Inventory scores before and after the pelvic examination in each study group.
Study question | Control group (n=58), mean (SD) | Intervention group (n=60), mean (SD) | |
1. I feel calm | −0.02 (1.1) | −0.7 (1.2) | .002 |
2. I feel secure | −0.1 (1.1) | −0.7 (1.2) | .007 |
3. I feel tense | −0.1 (1.0) | −0.5 (1.2) | .06 |
4. I feel strained | −0.2 (0.9) | −0.7 (1.1) | .01 |
5. I feel at ease | −0.3 (0.9) | −0.4 (1.2) | .91 |
6. I feel upset | −0.3 (0.9) | −0.5 (1.5) | .58 |
7. I am presently worrying over possible misfortunes | −0.3 (1.0) | −0.2 (1.2) | .58 |
8. I feel satisfied | −0.2 (0.9) | −0.2 (1.2) | .83 |
9. I feel frightened | −0.03 (0.8) | −0.2 (1.1) | .46 |
10. I feel uncomfortable | −0.6 (1.3) | −0.5 (1.4) | .68 |
11. I feel self-confident | −0.2 (0.9) | −0.3 (1.1) | .75 |
12. I feel nervous | −0.2 (0.8) | −0.2 (1.2) | .83 |
13. I feel jittery | −0.2 (0.8) | −0.4 (1.1) | .38 |
14. I feel indecisive | −0.2 (0.8) | −0.5 (1.2) | .12 |
15. I am relaxed | −0.2 (1.3) | −0.4 (1.4) | .39 |
16. I feel content | −0.4 (1.0) | −0.4 (1.4) | .77 |
17. I am worried | −0.4 (1.1) | −0.3 (1.4) | .57 |
18. I feel confused | −0.3 (0.9) | −0.5 (1.0) | .19 |
19. I feel steady | −0.1 (1.2) | −0.6 (1.2) | .06 |
20. I feel pleasant | −0.1 (0.5) | −0.2 (1.4) | .27 |
Total Spielberger State-Trait Anxiety Inventory score | −4.2 (9.0) | −7.9 (14.3) | .10 |
This study conducted in Cameroon aimed to assess the effect of watching a live VIA/VILI examination on women’s anxiety. The direct visualization of the pelvic examination was not associated with a reduction of anxiety as measured by the STAI score. When asked to report their emotional state through questions such as
The findings in this study appear to be in contradiction with previous data obtained by Walsh et al [
Previous studies have found that pelvic examinations can significantly increase women’s anxiety, thus discouraging them from attending screening and follow-up visits. As the anxiety of women participating in CC screening may be high, the negative emotional response associated with the pelvic examination can affect self-esteem, thus resulting in mood disorders such as depression and irritability [
The strengths of this study are the randomized and prospective design and the use of a measurement method that has previously been validated in the literature. Although the STAI is a standardized and validated questionnaire for Western countries, limited evidence has evaluated its use in settings such as in sub-Saharan Africa. The use of an alternative tool to measure participants’ anxiety may therefore have yielded different results.
One limitation of this study is that it took place at a 12-month follow-up visit, which means that all women had already undergone a gynecological examination with a VIA/VILI assessment. It is therefore possible that, as all women had already undergone the procedure, any intervention to reduce anxiety would be less influential. Another limitation is the cultural difference that may influence the perception of anxiety, which makes it difficult to generalize our study results to the rest of the worldwide population, in particular to that of industrialized countries. A limitation consists in the fact that there was no multiple comparison adjustment for statistically significant findings. Finally, the interviewer knew in which group the women had been randomized after the examination. This aspect may have introduced a potential bias, as knowing the participant’s group allocation may have influenced the way in which the STAI questions were asked.
Similarly, the participants were aware of their group allocation during the pelvic examination, as well as when filling the STAI form after it. Such an unmasked allocation may have influenced the study’s final results.
In conclusion, watching the VIA/VILI procedure in real time improved the women’s emotional state but did not reduce the periprocedural anxiety measured by the STAI score. Furthermore, larger studies should assess women’s satisfaction with watching their pelvic examination in real time to determine if this tool could be included in VIA/VILI routine practice. Moreover, further research should be focused on the effect on women’s anxiety when showing their cervical images immediately after the procedure rather than during it.
This study was supported by the Geneva University Hospitals, Geneva, Switzerland, and the Hospital of the District of Dschang, Cameroon. The funders had no role in the study conception and design or in the manuscript preparation and submission.
CONSORT‐EHEALTH checklist (V 1.6.1).
cervical cancer
control group
human papillomavirus
intervention group
low- and medium-income country
Spielberger State-Trait Anxiety Inventory
visual inspection with acetic acid
visual inspection with Lugol iodine
World Health Organization
None declared.