Trial Outcomes & Findings for Auriculotherapy as a Coping Strategy in Professional Nursing (NCT NCT01424072)

Results Overview

Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items. The scale is constructed by 8 different "domains": confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

75 participants

Primary outcome timeframe

after 60days

Results posted on

2013-05-31

Participant Flow

Recruitment was conducted between January and September 2011 at University Hospital. Study participants were professionals from different sectors of the hospital after the invitation and 109 people answered the Stress Symptoms List. Obeying the exclusion criteria, 75 subjects were enrolled and randomized into three groups.

Of the 109 subjects, 4 were eliminated for having a low level of stress and three for not belonging to nursing staff.

Participant milestones

Participant milestones
Measure	Auriculotherapy by Needles The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions. auriculotherapy by needles : 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.	Auriculotherapy by Seeds The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions. auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.	Control Group Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
Overall Study STARTED	27	26	22
Overall Study COMPLETED	27	26	22
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Auriculotherapy as a Coping Strategy in Professional Nursing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Auriculotherapy by Needles n=27 Participants The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions. auriculotherapy by needles : 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.	Auriculotherapy by Seeds n=26 Participants The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions. auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.	Control Group n=22 Participants Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions 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	27 Participants n=5 Participants	26 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	41.37 years STANDARD_DEVIATION 8.23 • n=5 Participants	45.57 years STANDARD_DEVIATION 6.40 • 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	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Region of Enrollment Brazil	27 participants n=5 Participants	26 participants n=7 Participants	22 participants n=5 Participants	75 participants n=4 Participants

PRIMARY outcome

Timeframe: after 60days

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

Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items. The scale is constructed by 8 different "domains": confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty).

Outcome measures

Outcome measures
Measure	Auriculotherapy by Needles n=27 Participants The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions. auriculotherapy by needles : 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.	Auriculotherapy by Seeds n=26 Participants The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions. auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.	Control Group n=22 Participants Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
Coping Strategy: Domain Social Support(After 60 Days)	8.81 units on a scale Standard Deviation 2.50	8.73 units on a scale Standard Deviation 3.2	11.32 units on a scale Standard Deviation 4.3

PRIMARY outcome

Timeframe: after 75 days

The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty).

Outcome measures

Outcome measures
Measure	Auriculotherapy by Needles n=27 Participants The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions. auriculotherapy by needles : 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.	Auriculotherapy by Seeds n=26 Participants The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions. auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.	Control Group n=22 Participants Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
Coping Strategy: Distancing Domain	6.33 units on a scale Standard Deviation 1.34	6.65 units on a scale Standard Deviation 1.46	7.36 units on a scale Standard Deviation 2.32

PRIMARY outcome

Timeframe: after 60 days

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

Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items. The scale is constructed by 8 different "domains": confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty).

Outcome measures

Outcome measures
Measure	Auriculotherapy by Needles n=27 Participants The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions. auriculotherapy by needles : 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.	Auriculotherapy by Seeds n=26 Participants The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions. auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.	Control Group n=22 Participants Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
Coping Strategy: Social Support Domain	8.81 units on a scale Standard Deviation 2.50	8.73 units on a scale Standard Deviation 3.2	11.32 units on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: after 60 days

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

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.

Outcome measures

Outcome measures
Measure	Auriculotherapy by Needles n=27 Participants The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions. auriculotherapy by needles : 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.	Auriculotherapy by Seeds n=26 Participants The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions. auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.	Control Group n=22 Participants Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
Stress Scale	59.84 units on a scale Standard Deviation 23.04	67.10 units on a scale Standard Deviation 23.77	67.87 units on a scale Standard Deviation 25.73

Adverse Events

Auriculotherapy by Needles

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Auriculotherapy by Seeds

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

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Auriculotherapy by Needles n=27 participants at risk The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions. auriculotherapy by needles : 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.	Auriculotherapy by Seeds n=26 participants at risk The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions. auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.	Control Group n=22 participants at risk Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
Psychiatric disorders Nightmares	0.00% 0/27 • after 4 sessions (one month) The main symptoms or adverse events were: Nightmares; Complaints of anxiety and unrest; Anxiety for food; Itching and redness in the auricular points.	3.8% 1/26 • Number of events 1 • after 4 sessions (one month) The main symptoms or adverse events were: Nightmares; Complaints of anxiety and unrest; Anxiety for food; Itching and redness in the auricular points.	0.00% 0/22 • after 4 sessions (one month) The main symptoms or adverse events were: Nightmares; Complaints of anxiety and unrest; Anxiety for food; Itching and redness in the auricular points.
Psychiatric disorders Complaints of anxiety and unrest	3.7% 1/27 • Number of events 1 • after 4 sessions (one month) The main symptoms or adverse events were: Nightmares; Complaints of anxiety and unrest; Anxiety for food; Itching and redness in the auricular points.	0.00% 0/26 • after 4 sessions (one month) The main symptoms or adverse events were: Nightmares; Complaints of anxiety and unrest; Anxiety for food; Itching and redness in the auricular points.	0.00% 0/22 • after 4 sessions (one month) The main symptoms or adverse events were: Nightmares; Complaints of anxiety and unrest; Anxiety for food; Itching and redness in the auricular points.
Psychiatric disorders Anxiety for food	3.7% 1/27 • Number of events 1 • after 4 sessions (one month) The main symptoms or adverse events were: Nightmares; Complaints of anxiety and unrest; Anxiety for food; Itching and redness in the auricular points.	0.00% 0/26 • after 4 sessions (one month) The main symptoms or adverse events were: Nightmares; Complaints of anxiety and unrest; Anxiety for food; Itching and redness in the auricular points.	0.00% 0/22 • after 4 sessions (one month) The main symptoms or adverse events were: Nightmares; Complaints of anxiety and unrest; Anxiety for food; Itching and redness in the auricular points.
Immune system disorders Itching and redness in the auricular point	3.7% 1/27 • Number of events 1 • after 4 sessions (one month) The main symptoms or adverse events were: Nightmares; Complaints of anxiety and unrest; Anxiety for food; Itching and redness in the auricular points.	0.00% 0/26 • after 4 sessions (one month) The main symptoms or adverse events were: Nightmares; Complaints of anxiety and unrest; Anxiety for food; Itching and redness in the auricular points.	0.00% 0/22 • after 4 sessions (one month) The main symptoms or adverse events were: Nightmares; Complaints of anxiety and unrest; Anxiety for food; Itching and redness in the auricular points.

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 Latin American Journal of Nursing, 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