Comparing Anxiety Levels and Pain Scores for Video-assisted and Traditional Informed Consent in Extracorporeal Shockwave Lithotripsy: A Prospective, Randomised, Controlled Study

Nurul Zubaidah Shahul Hameed *

Urology Unit, Surgical Department, Hospital Raja Perempuan Zainab II, Kelantan, Malaysia.

Devindran Manoharan

Department of Urology, Penang General Hospital, Penang, Malaysia.

Lee Say Bob

Department of Urology, Penang General Hospital, Penang, Malaysia.

Susan Woo

Department of Urology, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia.

*Author to whom correspondence should be addressed.


Abstract

Aims: Traditionally, informed consent involves verbal and/or written material provided to the patient by a treating clinician. Multimedia interventions improve patients’ knowledge and understanding during the informed consent process. This study aimed to compare pre-procedural anxiety levels and pain scores between educational video-assisted informed consent and traditional informed consent for extracorporeal shockwave lithotripsy (ESWL) at our centre.

Study Design: This was a prospective, randomised, controlled study conducted at two centres.

Place and Duration of Study: The study was conducted in two Urology centre Department of Urology, Penang General Hospital and Department of Urology, Hospital Kuala Lumpur between 15th May 2022 till 15th October 2022.

Methodology: The study group consisted of all adult patients undergoing ESWL in. both centres. A video presentation explaining the ESWL procedure was developed in two languages, and group allocation was randomised using a computer-based random number generator. Anxiety levels were assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire, visual analogue scale, and numerical rating scale used to collect data on pain scores.

Results: A total of 54 respondents, with a predominance of male patients (57.4%) and the majority of patients having completed secondary school education (53.7%). In comparing the two groups, the video-assisted respondents exhibited significantly lower anxiety scores regarding the procedure than those in the traditional group (p< 0.05). However, there were no statistically significant differences between the groups in terms of pain scores, both pre- and post-procedural.

Conclusion: Video-assisted informed consent can reduce procedure-related patient anxiety levels before ESWL; however, there was no difference in pain scores between the two consent methods. patients.

Keywords: Informed consent, video-assisted, ESWL, anxiety, pain score, randomized controlled trial


How to Cite

Hameed , N. Z. S., Manoharan , D., Bob, L. S., & Woo , S. (2024). Comparing Anxiety Levels and Pain Scores for Video-assisted and Traditional Informed Consent in Extracorporeal Shockwave Lithotripsy: A Prospective, Randomised, Controlled Study. Asian Journal of Research and Reports in Urology, 7(1), 1–9. Retrieved from https://journalajrru.com/index.php/AJRRU/article/view/112

Downloads

Download data is not yet available.

References

O’ Sullivan L, Feeney L, Crowley RK. et al. An evaluation of the process of informed consent: views from research participants and staff. Trials. 2021;22: 544. Available:https://doi.org/10.1186/s13063-021-05493-1

Nishimura A, Carey J, Erwin PJ, Tilburt JC, Murad MH, McCormick JB. Improving understanding in the research informed consent process: A systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics. 2013;14:28. Available:https://doi.org/10.1186/1472-6939-14-28.

Chill HH, Dior U, Shveiky D. Use of multimedia during informed consent: Novelty or necessity. Int Urogynecol J. 2019;30:1635–7. Available:https://doi.org/10.1007/s00192-019-04046-0. [Epub 2019 July 13]. PMID: 31302718.

Tait AR, Voepel-Lewis T. Digital multimedia: A new approach for informed consent? JAMA. 2015;313:463–4. Available:https://doi.org/10.1001/jama.2014.17122, PMID: 25647199.

Gesualdo F, Daverio M, Palazzani L, et al. Digital tools in the informed consent process: A systematic review. BMC Med Ethics. 2021;22:18. Available:https://doi.org/10.1186/s12910-021-00585-8

Paton EA, Davis SK, Gaylord N, Cao X, Gosain A. Impact of a multimedia teaching tool on parental anxiety and knowledge during the informed consent process. Pediatr Surg Int. 2018;34:1345–52. Available:https://doi.org/10.1007/s00383-018-4352-z

Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996;82:445–51. Available:https://doi.org/10.1097/00000539-199603000-00002.

Mohd Fahmi Z, Lai LL, Loh PS. Validation of the Malay version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Med J Malaysia. 2015;70:243–8. PMID: 26358022.

Aja B. The effects of pain on informed consent; 2017.

Gouda ADK, Ismail LM, Hamdan‐Mansour AM, Aboushady RMN. Effect of video assisted-teaching on level of knowledge, anxiety and pain among women undergoing colposcopy. Int J Health Sci. 2022;9376–92. Available:https://doi.org/10.53730/ijhs.v6nS5.11975

Bovelander E, Weltings S, Rad M, van Kampen P, Pelger RCM, Roshani H. The influence of pain on the outcome of extracorporeal shockwave lithotripsy. Curr Urol. 2019;12:81–7. Available:https://doi.org/10.1159/000489424

Shome D, Doshi K, Vadera S, Kumar V, Vyavahare SS, Kapoor R. Personalized video consent in blepharoplasty: A new paradigm in the preoperative consent giving process. J Cosmet Dermatol. 2021;20:2211–23. Available:https://doi.org/10.1111/jocd.14172

Sorrentino F, Petito A, Angioni S, D’Antonio F, Severo M, Solazzo MC, et al. Impact of anxiety levels on the perception of pain in patients undergoing office hysteroscopy. Arch Gynecol Obstet. 2021;303:999–1007. Available:https://doi.org/10.1007/s00404-020-05885-9.