Trial Outcomes & Findings for Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student (NCT NCT01420848)

Results Overview

The List of Symptoms of Stress is an evaluation questionnaire which consists of a list of 59 psycho-physiological and psychosocial stress, in which the subject must associate to each symptom of the four answers: never (0), rarely (1 ), often (2) or always (3). The scores are added together and the answers provide the level of stress the individual.In this questionnaire to score from 0 to 11 is void, 12 to 29 (low level), 30 to 59 (medium level), 60 to 120 (high level) and 120 to 177, very high level. Participants below 29 points were excluded.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

90 days

Results posted on

2013-07-15

Participant Flow

The recruitment of students was conducted between January and July 2011 at the Nursing School of Portuguese Beneficence Hospital. Eighty five people were invited and seventy one subjects were enrolled and randomized into 3 groups.

No sample size calculation was done for this study because the number of the population was small and it was decided to invite all students to attend nursing school test.

Participant milestones

Participant milestones
Measure	Auriculotherapy Group The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion. Two points were chosen to treat stress and anxiety (Shenmen and Brainstem). Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.	Control Group Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group	Placebo Group Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
Overall Study STARTED	24	25	22
Overall Study COMPLETED	24	25	22
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Auriculotherapy Group n=24 Participants The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion. Two points were chosen to treat stress and anxiety (Shenmen and Brainstem). Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.	Control Group n=25 Participants Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group	Placebo Group n=22 Participants Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.	Total n=71 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	24 Participants n=5 Participants	25 Participants n=7 Participants	22 Participants n=5 Participants	71 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	27.21 years STANDARD_DEVIATION 5.97 • n=5 Participants	28.68 years STANDARD_DEVIATION 6.57 • n=7 Participants	30.91 years STANDARD_DEVIATION 8.34 • n=5 Participants	28.93 years STANDARD_DEVIATION 6.96 • n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	64 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment Brazil	24 participants n=5 Participants	25 participants n=7 Participants	22 participants n=5 Participants	71 participants n=4 Participants

PRIMARY outcome

Timeframe: 90 days

Population: It was analysed only the subjects that ended the study.

The List of Symptoms of Stress is an evaluation questionnaire which consists of a list of 59 psycho-physiological and psychosocial stress, in which the subject must associate to each symptom of the four answers: never (0), rarely (1 ), often (2) or always (3). The scores are added together and the answers provide the level of stress the individual.In this questionnaire to score from 0 to 11 is void, 12 to 29 (low level), 30 to 59 (medium level), 60 to 120 (high level) and 120 to 177, very high level. Participants below 29 points were excluded.

Outcome measures

Outcome measures
Measure	Auriculotherapy Group n=24 Participants The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion. Two points were chosen to treat stress and anxiety (Shenmen and Brainstem). Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.	Control Group n=25 Participants Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group	Placebo Group n=22 Participants Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
Students Stress Levels	75.62 units on a scale Standard Deviation 26.50	67.72 units on a scale Standard Deviation 22.38	72.45 units on a scale Standard Deviation 25.65

SECONDARY outcome

Timeframe: 90 days

Population: It was analysed only the number of participants that ended the study.

The State-Trait Anxiety Inventory consists of 2 scales, each one containing 20 items. One of the scales evaluates state anxiety, characterized by subjective feelings of tension and apprehension, followed by autonomic nervous system responses at a given moment. Trait anxiety, assessed by the other scale, refers to a relatively stable tendency to perceive situations at threatening and react anxiously to them. The scores are divided into low, moderate, high and very high and are determined by the sum of 20 symptoms from a 5-point Likert-type scale.The range of scores is 20-80, the higher the score indicating greater anxiety for both the Trait and State Anxiety.

Outcome measures

Outcome measures
Measure	Auriculotherapy Group n=24 Participants The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion. Two points were chosen to treat stress and anxiety (Shenmen and Brainstem). Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.	Control Group n=25 Participants Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group	Placebo Group n=22 Participants Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
Students Anxiety Levels Trait Anxiety	52.58 units on a scale Standard Deviation 9.29	49.48 units on a scale Standard Deviation 7.57	51.18 units on a scale Standard Deviation 10.32
Students Anxiety Levels State Anxiety	54.04 units on a scale Standard Deviation 10.74	50.16 units on a scale Standard Deviation 10.79	51.59 units on a scale Standard Deviation 11.70

Adverse Events

Auriculotherapy Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo 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 Group n=24 participants at risk The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion. Two points were chosen to treat stress and anxiety (Shenmen and Brainstem). Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.	Control Group n=25 participants at risk Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group	Placebo Group n=22 participants at risk Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
Nervous system disorders Pain	4.2% 1/24 • Number of events 1 • 3 months Tenderness and pain at the auricular point after the treatment	0.00% 0/25 • 3 months Tenderness and pain at the auricular point after the treatment	0.00% 0/22 • 3 months Tenderness and pain at the auricular point after the treatment

Additional Information

Leonice Fumiko Sato Kurebayashi

University of São Paulo

Phone: (5511 991126023)

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