Anxiety
Conditions
Keywords
Anxiety, Satisfaction, Incomplete bladder emptying, Clean Intermittent Self-catheterization, Prolapse/incontinence surgery
Brief summary
To compare patient satisfaction and anxiety scores between female subjects undergoing urinary incontinence and/or pelvic reconstructive surgery who are instructed preoperatively in the technique of clean intermittent self-catheterization (CISC) by means of an instructional video and those who do not receive specific preoperative instruction in CISC, other than basic informed consent regarding risks of postoperative urinary retention.
Interventions
OTHEREducational video
Watching an educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Enrollment will be offered to all women undergoing pelvic reconstructive and/or urinary incontinence surgery by the DIvision of Urogynecology, Department of Obstetrics and Gynecology at Magee Womens Hospital.
Exclusion criteria
* Subjects who have performed CISC in the past will be excluded. * Subjects whose score on the MMSE reflects dementia (\<24) will be excluded. * Subjects anticipated to have placement of a suprapubic catheter placement at the time of surgery will be excluded. * Subjects deemed by the enrolling physician to be incapable of physically performing self-catheterization will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State-Trait Anxiety Inventory-State Scores | Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively | The STAI-S scale is a 20-item, Likert-type, validated measure, scored 20-80 with higher scores reflecting higher situational anxiety. STAI-S is designed to specifically assess current anxiety as opposed to baseline trait anxiety. Respondents rated their current feelings specific to bladder catheterization by answering items regarding bladder catheterization such as, I feel at ease or I feel upset. Responses ranged from 1 to 5 from not at all to very much so. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Scores - Visual Analogue Scores (VAS). | Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operatively | Secondary study measures included a study-specific visual analog scales (VAS, range 0-100 mm) to assess comfort with Clean Intermittent Self-Catheterization (CISC) and opinions on the CISC video. Higher VAS scores represent higher levels of comfort with CISC. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized to Not Watch Educational Video Randomized to not watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery. | 100 |
| Randomized to Watch Pre-operative Educational Video About Clea Randomized to watch pre-operative educational video about clean intermittent self-catheterization prior to prolapse/incontinence surgery. | 99 |
| Total | 199 |
Baseline characteristics
| Characteristic | Randomized to Not Watch Educational Video | Total | Randomized to Watch Pre-operative Educational Video About Clea |
|---|---|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 9.8 | 58.7 years STANDARD_DEVIATION 10.8 | 59.7 years STANDARD_DEVIATION 11.7 |
| Mini-Mental Status Examination | 30 units on a scale | 30 units on a scale | 30 units on a scale |
| Pelvic Floor Distress Inventory-20 | 84 units on a scale | 94 units on a scale | 103 units on a scale |
| Pelvic Floor Impact Questionnaire-7 | 41 units on a scale | 50 units on a scale | 59 units on a scale |
| Personal Health Questionnaire-9 | 2 units on a scale | 2 units on a scale | 2 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 99 Participants | 194 Participants | 95 Participants |
| Region of Enrollment United States | 100 participants | 199 participants | 99 participants |
| Sex: Female, Male Female | 100 Participants | 199 Participants | 99 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| State-Trait Anxiety Inventory-State scale | 37.9 units on a scale STANDARD_DEVIATION 11.6 | 39.3 units on a scale STANDARD_DEVIATION 11.7 | 40.7 units on a scale STANDARD_DEVIATION 11.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 93 | 32 / 91 |
| serious Total, serious adverse events | 0 / 100 | 0 / 99 |
Outcome results
Primary
State-Trait Anxiety Inventory-State Scores
The STAI-S scale is a 20-item, Likert-type, validated measure, scored 20-80 with higher scores reflecting higher situational anxiety. STAI-S is designed to specifically assess current anxiety as opposed to baseline trait anxiety. Respondents rated their current feelings specific to bladder catheterization by answering items regarding bladder catheterization such as, I feel at ease or I feel upset. Responses ranged from 1 to 5 from not at all to very much so.
Time frame: Baseline, after viewing educational video, after learning self-cathterization, 6 weeks post-operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Education Without Video Tutorial | State-Trait Anxiety Inventory-State Scores | Baseline | 37.9 units on a scale | Standard Deviation 11.6 |
| Arm 1: Education Without Video Tutorial | State-Trait Anxiety Inventory-State Scores | Voiding Trial Failure | 40.6 units on a scale | Standard Deviation 9.7 |
| Arm 1: Education Without Video Tutorial | State-Trait Anxiety Inventory-State Scores | Post-video | NA units on a scale | — |
| Arm 1: Education Without Video Tutorial | State-Trait Anxiety Inventory-State Scores | Discharge | 33.4 units on a scale | Standard Deviation 11.7 |
| Arm 1: Education Without Video Tutorial | State-Trait Anxiety Inventory-State Scores | 6-weeks postoperative | 30.2 units on a scale | Standard Deviation 10.9 |
| Randomized to Watch Educational Video About Clean Intermittent | State-Trait Anxiety Inventory-State Scores | Discharge | 35.6 units on a scale | Standard Deviation 13 |
| Randomized to Watch Educational Video About Clean Intermittent | State-Trait Anxiety Inventory-State Scores | 6-weeks postoperative | 32.7 units on a scale | Standard Deviation 13.4 |
| Randomized to Watch Educational Video About Clean Intermittent | State-Trait Anxiety Inventory-State Scores | Baseline | 40.7 units on a scale | Standard Deviation 11.7 |
| Randomized to Watch Educational Video About Clean Intermittent | State-Trait Anxiety Inventory-State Scores | Post-video | 37.7 units on a scale | Standard Deviation 12.5 |
| Randomized to Watch Educational Video About Clean Intermittent | State-Trait Anxiety Inventory-State Scores | Voiding Trial Failure | 42.5 units on a scale | Standard Deviation 11.9 |
Secondary
Patient Satisfaction Scores - Visual Analogue Scores (VAS).
Secondary study measures included a study-specific visual analog scales (VAS, range 0-100 mm) to assess comfort with Clean Intermittent Self-Catheterization (CISC) and opinions on the CISC video. Higher VAS scores represent higher levels of comfort with CISC.
Time frame: Baseline, post-operatively at time of discharge from hospital, 6 weeks post-operatively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Education Without Video Tutorial | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | Baseline-Worry | 44 participants |
| Arm 1: Education Without Video Tutorial | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | After viewing video-Worry | NA participants |
| Arm 1: Education Without Video Tutorial | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | Baseline-Feels catheterization would be difficult | NA participants |
| Arm 1: Education Without Video Tutorial | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | Postvideo-Feels catheterization would be difficult | NA participants |
| Arm 1: Education Without Video Tutorial | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | Baseline-CISC affect Satisfaction | 7 participants |
| Arm 1: Education Without Video Tutorial | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | After viewing video-Relieving fear/anxiety | NA participants |
| Arm 1: Education Without Video Tutorial | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | After viewing video-Video Helpful | NA participants |
| Arm 1: Education Without Video Tutorial | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | After viewing video-Comfort with catheterization | NA participants |
| Arm 1: Education Without Video Tutorial | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | Baseline-Comfort level | 36 participants |
| Randomized to Watch Educational Video About Clean Intermittent | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | Postvideo-Feels catheterization would be difficult | 22 participants |
| Randomized to Watch Educational Video About Clean Intermittent | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | Baseline-Comfort level | 36 participants |
| Randomized to Watch Educational Video About Clean Intermittent | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | Baseline-Worry | 44 participants |
| Randomized to Watch Educational Video About Clean Intermittent | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | Baseline-CISC affect Satisfaction | 7 participants |
| Randomized to Watch Educational Video About Clean Intermittent | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | Baseline-Feels catheterization would be difficult | 32 participants |
| Randomized to Watch Educational Video About Clean Intermittent | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | After viewing video-Video Helpful | 95 participants |
| Randomized to Watch Educational Video About Clean Intermittent | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | After viewing video-Comfort with catheterization | 52 participants |
| Randomized to Watch Educational Video About Clean Intermittent | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | After viewing video-Worry | 31 participants |
| Randomized to Watch Educational Video About Clean Intermittent | Patient Satisfaction Scores - Visual Analogue Scores (VAS). | After viewing video-Relieving fear/anxiety | 82 participants |