Use of Baxter Animated Retching Faces (BARF) Scale to Measure Nausea in Children Who Speak Spanish
Study Details
Study Description
Brief Summary
Pediatric research in the management of nausea has been limited by the absence of a reliable method to quantify the intensity of this subjective symptom. In adults, the visual analog scale (VAS) is an accurate tool, but this has not been shown to be reliable in young children. A scale is a series of points made on a line that will be used for measurement; a mark on the far left of the line shows little pain and the mark on the far right means alot of pain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
By default the most common objective outcome measure used in pediatric studies has been the incidence and number of emetic episodes. This measure, however, correlates poorly with the somatic subjective symptom of nausea. Apfel et al have shown that 30-40% of adult patients undergoing surgery have post discharge nausea and / or vomiting while 12% have vomiting. These data on nausea in adults were based on a visual analog scale for nausea. There are no data on the incidence of postoperative nausea in children since the severity of symptoms are difficult to measure as younger children are known to be unable to use the VAS reliably. Recently a pictorial scale for measuring nausea, the Baxter Animated Retching Faces (BARF) scale, has been developed and shown to have construct, content and convergent validity as an instrument to measure nausea in children. This was a two center study that was limited to children who could speak English. The clinical usefulness of this scale in determining the incidence of postoperative and post-discharge nausea in children has yet to be determined including the lowest age where it can be used reliably, the score associated with a patient's perception of a need for treatment, the minimum change in the scores of clinical relevance and the test-retest reliability when nausea is rated as not having changed. The score has also not been validated in children who speak Spanish. This study is designed to provide the missing information and will specifically look at the Spanish speaking population.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Nausea measurement by VAS and BARF All patients will be asked to rate their nausea on both the VAS and the BARF scales. For the nausea scales, the script would be: "Have you thrown up or felt like you were going to throw up before? How did your tummy feel then? We call that feeling of being sick to the stomach as nausea. For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel." (Point to the each face at the appropriate time). Which face is more like you feel right now?" For the VAS scale: On this line the far left indicates "No nausea" and the far right" Worst nausea ever." Can you show me on this line how much nausea you have right now? |
Outcome Measures
Primary Outcome Measures
- Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) [When awake and responding to commands in the post-anesthesia care unit (PACU)]
Subjects rated their pain and nausea at these time points: (1) upon waking in the PACU, (2) just before and (3) 30-60 mins after receiving analgesic or antiemetic therapy, and (4) upon discharge from PACU. Scales range from 0 to 10 (lower scores indicate no pain or nausea).
Secondary Outcome Measures
- Subjects Who Experienced Nausea and/or Vomiting After Discharge (PDNV) [First 24 postoperative hours]
The study design is a cross sectional study of patients undergoing surgery. There will be no group assignment, no placebo group and each patient will be his or her own control. All patients will be asked to assess their pain and nausea using the visual analogue scales, the modified faces scale and the BARF scale as described below in the preoperative and postoperative areas.
- Pain and/or Nausea/Vomiting Rescue Needed [Time in the PACU]
Incidence and/of pain or nausea/vomiting rescue medications administered during time in the PACU
Eligibility Criteria
Criteria
Inclusion Criteria:
- (1) Spanish speaking children (2) Age > 7 years but below 18 years (3) Elective surgery (4) American Society of Anesthesiologists physical status 1-3 (Free from major concurrent disorders) (5) Free from nausea and / or vomiting in the previous 24 hours (6) Cognitive and communicative ability to rate the intensity of symptoms as described below.
Exclusion Criteria:
- (1) Inability to understand or speak Spanish (2) Developmental delay (3) Blindness (4) Impaired cognitive or communicative abilities including inability to rate the intensity of symptoms (5) Surgical procedure where vision or hearing is anticipated to be impaired in the immediate postoperative period (6) Nausea and /or vomiting within 24 hours of procedure, (7) Patient or parental refusal to participate (8) Pregnant females
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Texas Children't Hospital | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Baylor College of Medicine
Investigators
- Principal Investigator: Mary A Felberg, MD, Baylor College of Medicine
Study Documents (Full-Text)
More Information
Publications
None provided.- H32424
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Nausea Measurement by VAS and BARF |
|---|---|
| Arm/Group Description | All patients will be asked to rate their nausea on both the VAS and the BARF scales. For the nausea scales, the script would be: "Have you thrown up or felt like you were going to throw up before? How did your tummy feel then? We call that feeling of being sick to the stomach as nausea. For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel." (Point to the each face at the appropriate time). Which face is more like you feel right now?" For the VAS scale: On this line the far left indicates "No nausea" and the far right" Worst nausea ever." Can you show me on this line how much nausea you have right now? |
| Period Title: Overall Study | |
| STARTED | 193 |
| PACU Analysis | 184 |
| COMPLETED | 82 |
| NOT COMPLETED | 111 |
Baseline Characteristics
| Arm/Group Title | Nausea Measurement by VAS and BARF |
|---|---|
| Arm/Group Description | All patients will be asked to rate their nausea on both the VAS and the BARF scales. For the nausea scales, the script would be: "Have you thrown up or felt like you were going to throw up before? How did your tummy feel then? We call that feeling of being sick to the stomach as nausea. For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel." (Point to the each face at the appropriate time). Which face is more like you feel right now?" For the VAS scale: On this line the far left indicates "No nausea" and the far right" Worst nausea ever." Can you show me on this line how much nausea you have right now? |
| Overall Participants | 184 |
| Age, Customized (years) [Mean (Standard Deviation) ] | |
| Age |
10.9
(3)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
74
40.2%
|
| Male |
110
59.8%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| United States |
184
100%
|
| Preoperative VAS Nausea (Normalized Values) (cm) [Mean (Full Range) ] | |
| Mean (Full Range) [cm] |
0.2
|
| Preoperative VAS Pain (Normalized Values) (cm) [Mean (Full Range) ] | |
| Mean (Full Range) [cm] |
0.4
|
| Preoperative FACES Pain (units on a scale) [Mean (Full Range) ] | |
| Mean (Full Range) [units on a scale] |
0.4
|
| Preoperative FACES Nausea (units on a scale) [Mean (Full Range) ] | |
| Mean (Full Range) [units on a scale] |
0.3
|
Outcome Measures
| Title | Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU) |
|---|---|
| Description | Subjects rated their pain and nausea at these time points: (1) upon waking in the PACU, (2) just before and (3) 30-60 mins after receiving analgesic or antiemetic therapy, and (4) upon discharge from PACU. Scales range from 0 to 10 (lower scores indicate no pain or nausea). |
| Time Frame | When awake and responding to commands in the post-anesthesia care unit (PACU) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some PACU data is partial due to subjects being uncooperative at times (n=5) or being asleep until just before discharge (n=2) |
| Arm/Group Title | PACU Time | Discharge From PACU |
|---|---|---|
| Arm/Group Description | Subject's rated their pain and nausea while in PACU | Subjects rated their pain and nausea upon discharge from PACU |
| Measure Participants | 177 | 175 |
| VAS Nausea |
0.6
|
0.4
|
| VAS Pain |
2.7
|
1.3
|
| FACES Nausea |
0.9
|
0.5
|
| FACES Pain |
2.7
|
1.6
|
| Title | Subjects Who Experienced Nausea and/or Vomiting After Discharge (PDNV) |
|---|---|
| Description | The study design is a cross sectional study of patients undergoing surgery. There will be no group assignment, no placebo group and each patient will be his or her own control. All patients will be asked to assess their pain and nausea using the visual analogue scales, the modified faces scale and the BARF scale as described below in the preoperative and postoperative areas. |
| Time Frame | First 24 postoperative hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Post-Discharge Analysis |
|---|---|
| Arm/Group Description | This includes all subjects who returned their diaries. |
| Measure Participants | 82 |
| Count of Participants [Participants] |
10
5.4%
|
| Title | Pain and/or Nausea/Vomiting Rescue Needed |
|---|---|
| Description | Incidence and/of pain or nausea/vomiting rescue medications administered during time in the PACU |
| Time Frame | Time in the PACU |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Nausea Measurement by VAS and BARF |
|---|---|
| Arm/Group Description | All patients will be asked to rate their nausea on both the VAS and the BARF scales. For the nausea scales, the script would be: "Have you thrown up or felt like you were going to throw up before? How did your tummy feel then? We call that feeling of being sick to the stomach as nausea. For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel." (Point to the each face at the appropriate time). Which face is more like you feel right now?" For the VAS scale: On this line the far left indicates "No nausea" and the far right" Worst nausea ever." Can you show me on this line how much nausea you have right now? |
| Measure Participants | 184 |
| Count of Participants [Participants] |
100
54.3%
|
Adverse Events
| Time Frame | Subjects were monitored for adverse events while active in the study (from enrollment until diaries were completed at 24 hours PACU discharge). | |
|---|---|---|
| Adverse Event Reporting Description | This is a minimal risk, cross-sectional study of pain and nausea using three scales. There was no randomization or intervention. | |
| Arm/Group Title | Nausea Measurement by VAS and BARF | |
| Arm/Group Description | All patients will be asked to rate their nausea on both the VAS and the BARF scales. For the nausea scales, the script would be: "Have you thrown up or felt like you were going to throw up before? How did your tummy feel then? We call that feeling of being sick to the stomach as nausea. For the BARF scale:These faces show children who feel no nausea at all, who feel a little bit nauseated, who feel even more nauseated, and these are children who have the most nausea it is possible to feel." (Point to the each face at the appropriate time). Which face is more like you feel right now?" For the VAS scale: On this line the far left indicates "No nausea" and the far right" Worst nausea ever." Can you show me on this line how much nausea you have right now? | |
All Cause Mortality |
||
| Nausea Measurement by VAS and BARF | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/193 (0%) | |
Serious Adverse Events |
||
| Nausea Measurement by VAS and BARF | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/193 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Nausea Measurement by VAS and BARF | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/193 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Mary Felberg |
|---|---|
| Organization | Baylor College of Medicine |
| Phone | 832-824-5800 |
| mafelber@texaschildrens.org |
- H32424