Trial Outcomes & Findings for Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients (NCT NCT02105740)

Last Updated: 2017-03-30

Results Overview

Comparison was made through the scores in the Visual Analogue Scale (VAS) to measure the effect of hypnosis in pain among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale ranged from 0 to 10 points, without subscales. The better outcome occurs when the mean of the second or the third week decrease 3 points comparing with the first week, or when the mean of the third week decrease 3 points comparing with the second week.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

The study was done with each patient in the first three consecutive weeks after randomization

Results posted on

2017-03-30

Participant Flow

The recruitment process was conducted from March to December 2015. Thirty nine patients were invited. They had cancer of digestive tract from both genders, of 40-70 years, with pain scores ≥ 3 by (EVA). Were excluded: patients that used psychotropic drugs, with psychiatric disorders, terminally ill cancer, hearing impaired and mentally disabled.

Were excluded: 3 patients weren't suggestible, 3 patients who had terminal cancer, 2 patients who reported low scores, and 7 patients for other reasons such as religious issues or not accepting the technique. One patient dropped out the treatment because he had limited mobility to return to the hospital.

Participant milestones

Participant milestones
Measure	Hypnosis Use of hypnosis in the reduction of the levels of pain, depression and anxiety. Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression.	Control Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain, anxiety and depression with the application of the scales. Control x Hypnosis Group: The control and hypnosis groups respond in 3 different distinct moments, with the Visual Analogue Scale (VAS) for the evaluation of pain, and the Hospital Anxiety and Depression Scale (HADS) to evaluate the depression and the anxiety. The first evaluation will be made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group, after the follow-up visit. The third evaluation will occur two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group will be compared in relation to the intensity of the pain, depression and anxiety.
Overall Study STARTED	12	12
Overall Study Second	12	11
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hypnosis n=12 Participants Use of hypnosis to reduct the levels of pain, depression and anxiety. Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same.	Control n=12 Participants Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales. Control : The control and experimental groups respond in 3 different moments to Visual Analog Scale (VAS) for the evaluation of pain, and to Hospital Anxiety and Depression Scale (HADS) to evaluate depression and the anxiety. The first meeting was made before the hypnosis. In the second meeting, within an interval of 7 days, the scales were applied in all patients. Before applying the scales, the hypnosis group was submitted to the session. The third meeting occurred two weeks later, where the scales were only applied to compare the groups.	Total n=24 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 6.6 • n=5 Participants	55.8 years STANDARD_DEVIATION 7.5 • n=7 Participants	55.5 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Brazil	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Pain	7.3 units on a scale STANDARD_DEVIATION 2.4 • n=5 Participants	5.6 units on a scale STANDARD_DEVIATION 2.0 • n=7 Participants	6.4 units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants
Anxiety	11.5 units on a scale STANDARD_DEVIATION 4.6 • n=5 Participants	11.3 units on a scale STANDARD_DEVIATION 4.4 • n=7 Participants	11.4 units on a scale STANDARD_DEVIATION 4.4 • n=5 Participants
Depression	9.8 units on a scale STANDARD_DEVIATION 5.3 • n=5 Participants	9.0 units on a scale STANDARD_DEVIATION 3.8 • n=7 Participants	9.4 units on a scale STANDARD_DEVIATION 4.5 • n=5 Participants

PRIMARY outcome

Timeframe: The study was done with each patient in the first three consecutive weeks after randomization

Population: 24 cancer patients were allocated. They were aged between 40-70 years, of both genders, with pain scores ≥ 3 measured by Visual Analogue Scale (VAS). One patient of the control group left the research.

Outcome measures

Outcome measures
Measure	Hypnosis n=12 Participants Use of hypnosis to change the levels of pain. Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms.	Control n=11 Participants Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain with the application of the Visual Analogue Scale (VAS). Control x Hypnosis Group: The control and the hypnosis groups respond in 3 different distinct moments, using the Visual Analogue Scale (VAS) to evaluate the pain. The first evaluation was made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation was made two weeks later, in order to provide a follow-up to assess the efficacy of the technique.
Change of Pain Score in the Visual Analogue Scale First Week	7.33 units on a scale Standard Deviation 2.38	5.58 units on a scale Standard Deviation 2.06
Change of Pain Score in the Visual Analogue Scale Second Week	3.67 units on a scale Standard Deviation 2.77	5.67 units on a scale Standard Deviation 3.36
Change of Pain Score in the Visual Analogue Scale Third Week	2.08 units on a scale Standard Deviation 2.61	4.75 units on a scale Standard Deviation 3.13

SECONDARY outcome

Timeframe: The study was done with each patient in the first three consecutive weeks after randomization

Population: Were allocated 24 cancer patients, aged between 40-70 years, of both genders, with depression and anxiety score ≥ 9 in Hospital Anxiety and Depression Scale (HADS). One patient of the control group left the research.

Comparison was made through the scores in the Hospital Anxiety and Depression Scale (HADS) to measure the effect of hypnosis in anxiety and depression among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale has 14 items, seven of which are directed to the evaluation of anxiety (HADS-A) and seven to depression (HADS-D). Each item can be scored from zero to three, establishing a score range of 0 to 21 points for each subscale. The better outcome occurs when the mean is lower or equal to 9 for each subscale. The subscales are independent for each result of depression and anxiety.

Outcome measures

Outcome measures
Measure	Hypnosis n=12 Participants Use of hypnosis to change the levels of pain. Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms.	Control n=11 Participants Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain with the application of the Visual Analogue Scale (VAS). Control x Hypnosis Group: The control and the hypnosis groups respond in 3 different distinct moments, using the Visual Analogue Scale (VAS) to evaluate the pain. The first evaluation was made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation was made two weeks later, in order to provide a follow-up to assess the efficacy of the technique.
Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) Anxiety First Week	11.50 units on a scale Standard Deviation 4.60	11.33 units on a scale Standard Deviation 4.41
Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) Anxiety Second Week	8.17 units on a scale Standard Deviation 3.76	11.50 units on a scale Standard Deviation 2.43
Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) Anxiety Third Week	7.50 units on a scale Standard Deviation 3.39	8.89 units on a scale Standard Deviation 5.96
Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) Depression First Week	9.75 units on a scale Standard Deviation 5.32	9.00 units on a scale Standard Deviation 3.76
Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) Depression Second Week	7.00 units on a scale Standard Deviation 5.46	8.75 units on a scale Standard Deviation 4.75
Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) Depression Third Week	6.25 units on a scale Standard Deviation 3.98	7.75 units on a scale Standard Deviation 5.10

Adverse Events

Hypnosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Gil Montenegro

Universidade de Brasília

Phone: 556181487323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place