Trial Outcomes & Findings for Acupressure and Relaxation for Nausea Control (NCT NCT00243269)
NCT ID: NCT00243269
Last Updated: 2015-06-18
Results Overview
Nausea was measured using a five-day patient report diary. Each day was divided into 4 sections: morning, afternoon, evening, and night. Patients reported severity of nausea for each period daily. Severity of nausea was assessed on a 7-point rating scale, anchored at one end by 1 = "Not at all nauseated" and at the other end by 7 = "Extremely nauseated." The description "Moderately nauseated" was centered on the scale below the 4. Average Nausea was the mean severity for the 20 reporting periods.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
83 participants
Primary outcome timeframe
Five days
Results posted on
2015-06-18
Participant Flow
Patients were recruited at three cancer clinics from Feb. 6, 2006 to April 23, 2009
Participant milestones
| Measure |
Control Handout and Control Tape.
Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, "Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study." Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
|
Active Handout and Control Tape.
Patients received two acupressure bands.
Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, "Wear Seabands for up to five days as needed to prevent or alleviate nausea." Patients' names were not on the prescription.
Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
|
Control Handout and Active Tape.
Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.
Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients' beliefs that the acupressure bands would be effective by focusing patients' attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well.
|
Active Handout and Active Tape.
Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.
Patients received the same expectancy-enhancing CD given to patients in Arm 3.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
31
|
11
|
12
|
29
|
|
Overall Study
COMPLETED
|
28
|
10
|
11
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Control Handout and Control Tape.
Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, "Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study." Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
|
Active Handout and Control Tape.
Patients received two acupressure bands.
Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, "Wear Seabands for up to five days as needed to prevent or alleviate nausea." Patients' names were not on the prescription.
Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
|
Control Handout and Active Tape.
Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.
Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients' beliefs that the acupressure bands would be effective by focusing patients' attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well.
|
Active Handout and Active Tape.
Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.
Patients received the same expectancy-enhancing CD given to patients in Arm 3.
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
3
|
Baseline Characteristics
Acupressure and Relaxation for Nausea Control
Baseline characteristics by cohort
| Measure |
Control Handout and Control Tape.
n=31 Participants
Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, "Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study." Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
|
Active Handout and Control Tape.
n=11 Participants
Patients received two acupressure bands.
Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, "Wear Seabands for up to five days as needed to prevent or alleviate nausea." Patients' names were not on the prescription.
Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
|
Control Handout and Active Tape.
n=12 Participants
Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.
Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients' beliefs that the acupressure bands would be effective by focusing patients' attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well.
|
Active Handout and Active Tape.
n=29 Participants
Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.
Patients received the same expectancy-enhancing CD given to patients in Arm 3.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Continuous
|
48.2 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
53.9 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
51.6 years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
11 participants
n=7 Participants
|
12 participants
n=5 Participants
|
29 participants
n=4 Participants
|
83 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Five daysPopulation: All patients who did not have protocol violations who provided evaluable data were included in the analyses. No data imputation was used.
Nausea was measured using a five-day patient report diary. Each day was divided into 4 sections: morning, afternoon, evening, and night. Patients reported severity of nausea for each period daily. Severity of nausea was assessed on a 7-point rating scale, anchored at one end by 1 = "Not at all nauseated" and at the other end by 7 = "Extremely nauseated." The description "Moderately nauseated" was centered on the scale below the 4. Average Nausea was the mean severity for the 20 reporting periods.
Outcome measures
| Measure |
Control Handout and Control Tape.
n=28 Participants
Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, "Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study." Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
|
Active Handout and Control Tape.
n=10 Participants
Patients received two acupressure bands.
Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, "Wear Seabands for up to five days as needed to prevent or alleviate nausea." Patients' names were not on the prescription.
Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
|
Control Handout and Active Tape.
n=11 Participants
Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.
Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients' beliefs that the acupressure bands would be effective by focusing patients' attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well.
|
Active Handout and Active Tape.
n=25 Participants
Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.
Patients received the same expectancy-enhancing CD given to patients in Arm 3.
|
|---|---|---|---|---|
|
Five-day Nausea Diary
|
2.0 Units on scale
Standard Deviation 1.1
|
2.1 Units on scale
Standard Deviation 1.7
|
2.1 Units on scale
Standard Deviation 0.9
|
1.9 Units on scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 5 daysHealth-Related Quality of Life was assessed using the Functional Assessment of Cancer Therapy Scale - General (FACT-G). The FACT-G is a 28-item scale developed specifically for use in cancer clinical trials. Possible scores range from a low of 0 to a high of 112. Along with a total score representing HRQL, there are psychometrically validated subscales of physical, functional, social, and cognitive-emotional status. It has become one of the most commonly used measures in oncology, and we have used this scale in our previous studies.
Outcome measures
| Measure |
Control Handout and Control Tape.
n=28 Participants
Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, "Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study." Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
|
Active Handout and Control Tape.
n=10 Participants
Patients received two acupressure bands.
Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, "Wear Seabands for up to five days as needed to prevent or alleviate nausea." Patients' names were not on the prescription.
Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
|
Control Handout and Active Tape.
n=11 Participants
Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.
Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients' beliefs that the acupressure bands would be effective by focusing patients' attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well.
|
Active Handout and Active Tape.
n=25 Participants
Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.
Patients received the same expectancy-enhancing CD given to patients in Arm 3.
|
|---|---|---|---|---|
|
Health Related Quality of Life
|
75.2 Units on scale
Standard Deviation 15.2
|
74.6 Units on scale
Standard Deviation 14.9
|
70.9 Units on scale
Standard Deviation 13.6
|
75.9 Units on scale
Standard Deviation 17.2
|
Adverse Events
Control Handout and Control Tape.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Handout and Control Tape.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Handout and Active Tape.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Handout and Active Tape.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place