Use of a multimedia module to aid the informed consent process in patients undergoing gynecologic laparoscopy for pelvic pain: randomized controlled trial.
OBJECTIVE
To determine whether providing additional information to the standard consent process, in the form of a multimedia module (MM), improves patient knowledge about operative laparoscopy without increasing anxiety.


METHODS
Randomized controlled trial (Canadian Task Force classification I).


METHODS
Two outpatient gynecologic clinics, one in a private hospital and the other in a public teaching hospital.


METHODS
Forty-one women aged 19 to 51 years (median, 35.6 years) requiring operative laparoscopy for investigation and treatment of pelvic pain.


METHODS
Following the standard informed consent process, patients were randomized to watch the MM (intervention group, n = 21) or not (control group, n = 20). The surgeon was blinded to the group assignments. All patients completed a knowledge questionnaire and the Spielberger short-form State-Trait Anxiety Inventory. Six weeks after recruitment, patients completed the knowledge questionnaire and the State-Trait Anxiety Inventory a second time to assess knowledge retention and anxiety scores.


RESULTS
Patient knowledge of operative laparoscopy, anxiety level, and acceptance of the MM were recorded. The MM intervention group demonstrated superior knowledge scores. Mean (SE) score in the MM group was 11.3 (0.49), and in the control group was 7.9 (0.50) (p <.001) (maximum score, 14). This did not translate into improved knowledge scores 6 weeks later; the score in the MM group was 8.4 (0.53) vs. 7.8 (0.50) in the control group (p = .44). There was no difference in anxiety levels between the groups at intervention or after 6 weeks. Overall, patients found the MM acceptable, and 18 women (86%) in the intervention group and 12 (60%) in the control group stated they would prefer this style of informed consent in the future.


CONCLUSIONS
Use of an MM enhances the informed consent process by improving patient knowledge, in the short term, without increasing anxiety.
Department of Endosurgery, Mercy Hospital for Women, Melbourne, Australia. Electronic address: lellett@mercy.com.au.
Lenore
L
Ellett
Department of Endosurgery, Mercy Hospital for Women, Melbourne, Australia.
Rocio
R
Villegas
Victorian Orthopaedic Foot and Ankle Clinic, Melbourne, Australia.
Andrew
A
Beischer
Department of Endosurgery, Mercy Hospital for Women, Melbourne, Australia.
Nicole
N
Ong
Department of Endosurgery, Mercy Hospital for Women, Melbourne, Australia.
Peter
P
Maher
D000328:Adult; D001007:Anxiety; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D010535:Laparoscopy; D008875:Middle Aged; D019212:Multimedia; D010353:Patient Education as Topic / Q000379:methods*; D017699:Pelvic Pain / Q000601:surgery*; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D055815:Young Adult
Gynecologic laparoscopy; Informed consent; Multimedia module; Patient education; Video