Trial Outcomes & Findings for Application of Auriculotherapy on Nursing Professional Stress Levels (NCT NCT01141374)

Last Updated: 2013-01-24

Results Overview

Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): \>120 points.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

after 30 days

Results posted on

2013-01-24

Participant Flow

Recruitment was conducted between January and July 2010 at University Hospital. Study participants were professionals from different sectors of the hospital after the invitation and 109 people answered the first questionnaire of stress (LSS). Obeying the exclusion criteria, 75 subjects were enrolled and randomized into three groups.

Withdrawal:employees went on vacation(7),sick leave(2), lost treatment for loss of time, forgetfulness,difficulty of rescheduling (12), withdrawal due to side effects, in this case, nightmares (1); low score (1), not belonging to the nursing staff (3), failure to attend the first session (7) not having completed the questionnaires (1)

Participant milestones

Participant milestones
Measure	Auriculotherapy by Seeds Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.	Auriculotherapy by Needles Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.	Control Group untreated group
Overall Study STARTED	26	27	22
Overall Study COMPLETED	26	27	22
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Application of Auriculotherapy on Nursing Professional Stress Levels

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Auriculotherapy by Seeds n=26 Participants Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.	Auriculotherapy by Needles n=27 Participants Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.	Control Group n=22 Participants untreated group	Total n=75 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
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	27 Participants n=7 Participants	22 Participants n=5 Participants	75 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	45.57 years STANDARD_DEVIATION 6.40 • n=5 Participants	41.37 years STANDARD_DEVIATION 8.23 • n=7 Participants	39.25 years STANDARD_DEVIATION 13.17 • n=5 Participants	42.06 years STANDARD_DEVIATION 9.27 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	21 Participants n=5 Participants	71 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment Brazil	26 participants n=5 Participants	27 participants n=7 Participants	22 participants n=5 Participants	75 participants n=4 Participants
score stress	63.27 scores on a scale STANDARD_DEVIATION 26.05 • n=5 Participants	66.82 scores on a scale STANDARD_DEVIATION 18.56 • n=7 Participants	54.36 scores on a scale STANDARD_DEVIATION 15.90 • n=5 Participants	61.48 scores on a scale STANDARD_DEVIATION 20.17 • n=4 Participants

PRIMARY outcome

Timeframe: after 30 days

Population: Of the 109 subjects, four were eliminated for having a low level of stress and 3 for not belonging to nursing staff. Of the 105, 7 didn't appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one did not complete the questionnaire, seven went on vacation or sick leave (2).

Outcome measures

Outcome measures
Measure	Control Group n=22 Participants Without intervention	Needle Group n=27 Participants Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).	Seeds Group n=26 Participants They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).
Stress Levels After 4 Sessions (2nd Evaluation)	49.68 units on a scale Standard Deviation 17.99	54.69 units on a scale Standard Deviation 27.10	54.00 units on a scale Standard Deviation 25.04

SECONDARY outcome

Timeframe: after 60 and 75 days

Population: 75 participants were assessed

Scale Information: Stress Symptoms List (LSS) with 60 items Low score (better outcome): 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): \>120 points.

Outcome measures

Outcome measures
Measure	Control Group n=22 Participants Without intervention	Needle Group n=27 Participants Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).	Seeds Group n=26 Participants They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).
Stress Levels(3rd and 4th Evaluation) 3rd evaluation	67.87 units on a scale Standard Deviation 25.73	59.84 units on a scale Standard Deviation 23.04	67.10 units on a scale Standard Deviation 23.77
Stress Levels(3rd and 4th Evaluation) follow-up	72.62 units on a scale Standard Deviation 31.51	55.54 units on a scale Standard Deviation 25.26	69.20 units on a scale Standard Deviation 30.03

Adverse Events

Auriculotherapy by Seeds

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Auriculotherapy by Needles

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Auriculotherapy by Seeds n=26 participants at risk Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.	Auriculotherapy by Needles n=27 participants at risk Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.	Control Group n=22 participants at risk untreated group
Psychiatric disorders abnormal dreams	3.8% 1/26 • Number of events 1 • one month	0.00% 0/27 • one month	0.00% 0/22 • one month
Skin and subcutaneous tissue disorders allergy	0.00% 0/26 • one month	3.7% 1/27 • Number of events 1 • one month	0.00% 0/22 • one month
Psychiatric disorders increase apettite	0.00% 0/26 • one month	3.7% 1/27 • Number of events 1 • one month	0.00% 0/22 • one month
Psychiatric disorders anxiety	0.00% 0/26 • one month	3.7% 1/27 • Number of events 1 • one month	0.00% 0/22 • one month

Additional Information

Leonice Fumiko Sato Kurebayashi

University of São Paulo

Phone: 55-11-91126023

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The copyright of the search results are the exclusive property of the Journal of School Nursing, University of Saint Paul, barring any reproduction, in whole or in part in any form or means of printed or electronic, without the prior and necessary authorization is requested.
Publication restrictions are in place

Restriction type: OTHER