Educational Video and Peri-operative Anxiety

Anxiety Disorders Clinical Trial

Official title:

The Effect of Informational Videos on Preoperative Anxiety and Satisfaction Levels in Patients Undergoing Elective Ambulatory Surgery. A Case-control Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581097
• Other study ID #: CERU-1801
• Status: Completed
• Phase: N/A
• Start date: February 1, 2013
• Est. completion date: June 10, 2018

Study information

• Verified date: August 2019
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Preoperative anxiety is a common problem with an impact on surgical outcome, anaesthetic drug dosage and patient's satisfaction. An important component of preoperative anxiety is due to concerns related to anaesthesia. Appropriate patients information has been shown to reduce preoperative anxiety level and this can be effectively achieved through a video. The aim of this study is to assess the impact of an informative video about the anaesthesia technique on patient's preoperative anxiety levels before minor ambulatory procedures.

The study design is a prospective, randomized, controlled clinical trial, where we use of short patient educational video to reduce preoperative anxiety level, explaining all sequence of major events between the arrival in the operating room and the performance of anaesthesia.

Description:

Anxiety is a common problem in patients undergoing invasive procedures, arriving in some studies up to 60-80%. Perioperative anxiety is correlated with hemodynamic effects (such as arterial hypertension and arrhythmias), it can have an impact on final surgical outcome, on anaesthetics drug dosage, and also with an growth about the perception of post-operative pain, leading to a substantial increase in analgesics dose and the number of post-operative hospitalization days. Finally, perioperative anxiety can reduce the patient's overall satisfaction with the quality of perioperative care.

Patients' satisfaction is largely based on their expectations and it forms part of the surgeon's reward: satisfied patients are more likely to maintain a good relationship with the surgeon, abstain from so called "doctor shopping", avoid malpractice litigations and recommend their surgeon to others. Last but not least, satisfied patients are more likely to comply with postoperative prescriptions and attend follow-up appointments. In non-life threatening procedures however, the main source of preoperative anxiety is often the outlook of anaesthesia rather than surgery itself, this being mainly related to a lack of enough information about the anaesthetic procedure. These fears are largely underestimated in routine minor procedures (such as ambulatory surgery) and thus risk to be not properly addressed. Due to lack of time and resources, this could have a significant impact on global patient satisfaction. Also if major complications (e.g. cardiac mortality) are surgery-related, anxiety is also associated with poor surgical outcome. How to identify and treat patients who will likely benefit from more information about anaesthesia is an important question that remains relatively unaddressed. However, it's known that more information about surgery reduces the level of anxiety and apprehension.

Some strategies have been developed to try to reduce pre-operative stress: deliver clinical information has proven to be able to relieve patient anxiety. Written information has recognised useful, but not all patients have shown the same degree of culture needed to read and understand texts. The use of multimedia information (such as videos) has already been studied and some trials have shown a certain anxiolytic effect, but data are conflicting. A part of this disparity probably derives from differences in methodology and culture between patients.

For these reasons the investigators developed a trial using a short educational video about the global management of local anaesthesia on outpatient hand surgery. The aim of this study is to assess the impact of this educational video about perioperative patient's anxiety levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 10, 2018
• Est. primary completion date: May 30, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients older than 18 years,

• American Society Anesthesiology (ASA) score I-III patients

• patients undergoing elective hand-surgery operation

• patients anesthetized by IntraVenous Regional Anesthesia (IVRA)

Exclusion Criteria:

• patient refusal,

• on-going anxiolytic or anti-depressive therapy,

• diagnosis of anxiety or psychiatric disorders,

• general contraindications to IVRA,

• limited compliance

• language barriers

Related Conditions & MeSH terms

• Ambulatory Surgical Procedures
• Anxiety Disorders

Intervention

Other:
• Video Group
Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of Intra-Venous Regional Anesthesia (IVRA)

Locations

Country	Name	City	State
Switzerland	Andrea Saporito MD	Bellinzona

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (22)

Arabul M, Kandemir A, Çelik M, Alper E, Akpinar Z, Aslan F, Vatansever S, Ünsal B. Impact of an information video before colonoscopy on patient satisfaction and anxiety. Turk J Gastroenterol. 2012;23(5):523-9. — View Citation

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Badner NH, Nielson WR, Munk S, Kwiatkowska C, Gelb AW. Preoperative anxiety: detection and contributing factors. Can J Anaesth. 1990 May;37(4 Pt 1):444-7. — View Citation

Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307. — View Citation

Cornoiu A, Beischer AD, Donnan L, Graves S, de Steiger R. Multimedia patient education to assist the informed consent process for knee arthroscopy. ANZ J Surg. 2011 Mar;81(3):176-80. doi: 10.1111/j.1445-2197.2010.05487.x. Epub 2010 Oct 1. — View Citation

Crabtree TD, Puri V, Bell JM, Bontumasi N, Patterson GA, Kreisel D, Krupnick AS, Meyers BF. Outcomes and perception of lung surgery with implementation of a patient video education module: a prospective cohort study. J Am Coll Surg. 2012 May;214(5):816-21 — View Citation

Danino AM, Chahraoui K, Frachebois L, Jebrane A, Moutel G, Herve C, Malka G. Effects of an informational CD-ROM on anxiety and knowledge before aesthetic surgery: a randomised trial. Br J Plast Surg. 2005 Apr;58(3):379-83. — View Citation

Edward GM, v d Naald N, Oort FJ, de Haes HC, Biervliet JD, Hollmann MW, Preckel B. Information gain in patients using a multimedia website with tailored information on anaesthesia. Br J Anaesth. 2011 Mar;106(3):319-24. doi: 10.1093/bja/aeq360. Epub 2010 Dec 10. — View Citation

Eley VA, Searles T, Donovan K, Walters E. Effect of an anaesthesia information video on preoperative maternal anxiety and postoperative satisfaction in elective caesarean section: a prospective randomised trial. Anaesth Intensive Care. 2013 Nov;41(6):774- — View Citation

Grossi G, Perski A, Feleke E, Jakobson U. State anxiety predicts poor psychosocial outcome after coronary bypass surgery. Int J Behav Med. 1998;5(1):1-16. — View Citation

Hering K, Harvan J, Dangelo M, Jasinski D. The use of a computer website prior to scheduled surgery (a pilot study): impact on patient information, acquisition, anxiety level, and overall satisfaction with anesthesia care. AANA J. 2005 Feb;73(1):29-33. — View Citation

Herrmann KS, Kreuzer H. A randomized prospective study on anxiety reduction by preparatory disclosure with and without video film show about a planned heart catheterization. Eur Heart J. 1989 Aug;10(8):753-7. — View Citation

Jlala HA, French JL, Foxall GL, Hardman JG, Bedforth NM. Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia. Br J Anaesth. 2010 Mar;104(3):369-74. doi: 10.1093/bja/aeq002. Ep — View Citation

Jones MP, Ebert CC, Sloan T, Spanier J, Bansal A, Howden CW, Vanagunas AD. Patient anxiety and elective gastrointestinal endoscopy. J Clin Gastroenterol. 2004 Jan;38(1):35-40. — View Citation

Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review. — View Citation

Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. — View Citation

Morgan J, Roufeil L, Kaushik S, Bassett M. Influence of coping style and precolonoscopy information on pain and anxiety of colonoscopy. Gastrointest Endosc. 1998 Aug;48(2):119-27. — View Citation

Pager CK. Randomised controlled trial of preoperative information to improve satisfaction with cataract surgery. Br J Ophthalmol. 2005 Jan;89(1):10-3. — View Citation

Ramsay MA. A survey of pre-operative fear. Anaesthesia. 1972 Oct;27(4):396-402. — View Citation

Sørlie T, Busund R, Sexton J, Sexton H, Sørlie D. Video information combined with individualized information sessions: Effects upon emotional well-being following coronary artery bypass surgery--A randomized trial. Patient Educ Couns. 2007 Feb;65(2):180-8. Epub 2006 Sep 7. — View Citation

Takahashi Y, Tanaka H, Kinjo M, Sakumoto K. Prospective evaluation of factors predicting difficulty and pain during sedation-free colonoscopy. Dis Colon Rectum. 2005 Jun;48(6):1295-300. — View Citation

Zieren J, Menenakos C, Mueller JM. Does an informative video before inguinal hernia surgical repair influence postoperative quality of life? Results of a prospective randomized study. Qual Life Res. 2007 Jun;16(5):725-9. Epub 2007 Feb 8. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)	Primary outcome measure is to see and analyze any difference in preoperative anxiety between the video and control group, measured on our Adapted Visual Analogue Scale (VAS-A). Scale range is 0 to 5, where 0 means no anxiety, while 5 means maximal anxiety. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of regional anesthesia.	2 hours
Secondary	Degree of Satisfaction	To perceive any disparity in patient's satisfaction degree measured through final questionnaire. A satisfaction questionnaire with evaluation from 0 (min) to 10 (max) regarding this topics. Higher values represent the better outcome, lower values represent the worse outcome.	3 hours
Secondary	Vital Parameters 1: Arterial Blood Pressure	To see any variance in vital parameters that are usually affected by anxiety, like arterial blood pressure [mmHg] in all patients.	2 hours
Secondary	Vital Parameters 2: Respiratory Rate	To see any variance in vital parameters that are usually affected by anxiety like respiratory rate [breath per minute] in all patients.	2 hours
Secondary	Vital Parameters 3: Heart Rate	To see any variance in vital parameters that are usually affected by anxiety like heart rate [beat per minute] in all patients.	2 hours
Secondary	First Subgroups Analyze: Anxious Patients	A subgroup analysis was performed applied to specific subgroups, like anxious patients.	2 hours
Secondary	Second Subgroups Analyze: Higher Anxiety Score	A subgroup analysis was performed applied to specific subgroups, like patients with higher anxiety assessment result, identified to have 3 or more on the 5 point on Visual Analog Scale - Adapted (VAS-A) score (ranging from 1 - no anxious - to 5 - totally anxious).	2 hours
Secondary	Third Subgroup Analyze: First Experience With Surgery.	A subgroup analysis was performed applied to specific subgroups, like patients at their first experience with surgery, identified by specific questionnaire.	2 hours