Hypnosis/Hypnotherapy

To identify and synthesize the evidence for mind-body interventions for which the evidence suggests benefit for at least two of the three cluster symptoms of pain, fatigue, and sleep disturbance.

Databases searched were CINAHL, MEDLINE, and PsycINFO through March 2009.

Search keywords were guided imagery, hypnosis, relaxation, biofeedback, cognitive behavioral therapy, coping skills training, meditation, virtual reality, music AND cancer AND fatigue, sleep disturbance, sleep difficulty, insomnia, and pain.

Studies were included in the review if they

• Were limited to research
• Included adults aged 18 years and older
• Included mind-body activities that involved primarily mental activity that could be performed by almost all patients
• Included pain, fatigue, or sleep among study dependent variables.

Studies were excluded if they

• Involved the use of yoga
• Involved patients in whom a diagnosis of cancer was not yet established
• Had a sample that included people without cancer.

A total of 47 studies were identified. In four of those, all testing virtual reality, only the symptom of fatigue was measured, so these were eliminated.

The final sample included 43 studies. Study sample sizes and total patients involved across studies were not reported.

Relaxation

Six studies examined relaxation interventions in hospitalized patients, outpatients with chronic pain, and women with early-stage breast cancer.

• Significantly greater pain relief was obtained with progressive muscle relaxation compared to massage, usual treatment, mood manipulation, distraction, and controls.
• One study found no difference in pain between a daily relaxation exercise and distraction.
• Training in muscle relaxation did not improve fatigue in one study compared to provision of information.
• In one study, muscle relaxation improved sleep compared to usual treatment controls.

Imagery and Hypnosis

Six studies examined imagery and hypnosis.

• In four studies, imagery was used in hospitalized patients with cancer pain, and beneficial effects were reported.
• One study found no differences in pain or fatigue between patients with an imagery intervention and those receiving standard care.
• Four studies used imagery in comparison to cognitive-behavioral therapy (CBT) and combined imagery with relaxation. Of those, one study reported no significant effect, two reported significant pain reduction, and one reported significant reduction in fatigue and sleep disturbance.

Cognitive Behavioral Therapy (CBT)/Coping Skills Training (CST)

Twenty-one studies tested CBT/CST.

• In three studies, fatigue was the primary focus. Significantly more improvement in fatigue was reported with a six- to 12-week CBT/CST intervention compared to usual treatment and controls.
• Three studies evaluated CST effects on the combination of pain and fatigue. In all of these, a one-session CST intervention resulted in no difference in symptoms compared to controls.
• Seven studies evaluated the effects of CBT/CST on fatigue and sleep disturbance. One study reported a decreased incidence of fatigue and sleep disturbance using an audio recording for coping skills training prior to chemotherapy. Two studies reported improvement in sleep with a four- to eight-week CBT intervention, but only one of these also reported improvement in fatigue. One study reported improvement in sleep and fatigue with a five-session CBT intervention, two other studies showed improvement in sleep but no change in fatigue, and one study reported no improvement in either of these two symptoms.
• Four studies reported effects of CBT/CST on all three symptoms concurrently. One showed improvement in fatigue and sleep but no impact on pain. One study reported less sleep disturbance but no difference in pain or fatigue. One reported lower ratings of worst pain immediately after the CBT program and greater reduction in pain and fatigue six months after the intervention compared to controls. One study found no differences in any of the three symptoms with a CST intervention.

Meditation

Four studies were included.

• Three of these studies used mindfulness-based interventions. One study reported significant improvements in both fatigue and sleep among outpatients who participated in an eight-week intervention.

Music

• Four studies looked at the effect of music on pain. Two studies found significant improvements in a pre-/posttest design using 30 minutes of preferred music among hospitalized patients. Two other studies found no difference in pain with listening to music compared to control groups.
• Two studies tested a music intervention on fatigue. One found a significant effect, and one found no difference in fatigue between intervention and control groups.

Findings of this review were equivocal.

• Although the authors stated a criterion for inclusion of examination of at least two of the three symptoms of interest, the review appeared to include studies in which only one of these symptoms was reported.
• Few investigators used multisymptom interventions and evaluations.
• Measures of symptom clusters were not been well identified.
• Some instruments were stated to potentially be more sensitive; however, the scales and individual items that were most useful to measure this symptom cluster were not determined.
• Timing, dosage, and frequency of interventions varied among studies, making it difficult to draw systematic conclusions. Most music interventions were very brief.
• This review did not provide study details, such as clear sample descriptions, sample sizes, or actual statistical results, and no effect sizes were calculated, although some studies used the same outcome measures.

Although the findings did not clearly demonstrate the effects of these interventions across studies, the authors concluded that these interventions hold promise. Although such interventions carry minimal risk to patients, some interventions would require substantial time and resource commitment to provide.

Both the hypnosis and attention control sessions were standardized and provided for patients individually by clinical psychologists. All four interventionists were PhD-level clinical psychologists trained in the use of hypnosis in medical settings. The hypnosis intervention was provided in a 15-minute session on the morning of surgery one hour before surgery. Sessions included a relaxation-based induction (including imagery for muscle relaxation), suggestions for relaxation and peace, specific symptom-focused suggestions, a deepening procedure, and instructions for how patients could use hypnosis on their own following the intervention session. Patients in the attention control condition spent identical amounts of time with the same interventionists that led the hypnosis intervention. Patients were allowed to direct the flow of the conversation, and therapists provided supportive/empathic comments according to standardized procedures. Patient outcome measures were evaluated before discharge on the same day of surgery. Interventions were based on previously published work.

• The sample included 200 patients with breast cancer (mean age = 48.5 years) scheduled to undergo excisional breast biopsy or lumpectomy. 
• The majority of patients were white (intervention group = 71%, control group = 55%), and about half were married (intervention group = 50%, control group = 45%).
• Patients in the hypnosis group received less intraoperative medications than patients in the control group. 
• Patients were not eligible if they were scheduled for mastectomy or lumpectomy with full axillary dissection or if they had any uncontrolled major comorbid mental or physical illness.

Patients were recruited from two Mount Sinai Medical Center surgical practices.

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial:

1. Hypnosis (n = 105)
2. Attention control (n = 95).

Visual analog scales (VASs)

A MANOVA showed an overall effect of the intervention on the six outcomes (as assessed by VASs), including patient-reported pain intensity, pain unpleasantness, nausea, fatigue, discomfort, and emotional upset (p < 0.0001). One-way ANOVAs of the effects of the intervention on VAS outcomes revealed that each outcome was statistically significantly lower in patients in the intervention group compared to those in the control group. In all cases, mean differences were clinically meaningful.

A cost-effectiveness analysis revealed that the intervention group had reduced costs compared to the patients in the attention control condition. These cost savings were primarily a result of reduced time in surgery in the hypnosis group.

• Patients were not blinded to group assignment because patients in the hypnosis group had to be aware and actively participate in the intervention.
• Formal assessment of the effectiveness of blinding research and clinical staff was not conducted.
• The study did not analyze the long-term effects of the intervention.

To test the effectiveness of a psychological intervention combining cognitive-behavioral therapy (CBT) and hypnosis (CBTH) to treat radiotherapy-related fatigue.

Forty-five patients were randomized to two groups:  CBTH and standard medical care. Weekly and daily fatigue were measured with two covariates:  neuroticism and history of chemotherapy. In the CBTH group, the patients participated in a 15-minute hypnosis session with guided imagery and suggestions for reduced fatigue and a sense of relaxation and energy. Patients were given a CD of the hypnosis intervention to listen to at home. The therapist provided a 30-minute CBT skills session, including how to recognize negative beliefs, consequences of those beliefs, how to change these, and how to practice behavioral strategies and exercise to manage treatment-related fatigue. The therapist reviewed information and progress with each patient twice weekly for a total of 12 sessions in 5- to 15-minute sessions.

• The sample was comprised of 42 patients (100% female). 
• Patients were older than 18 years.
• Mean age was 53.45 years (standard deviation [SD] = 10.43 years) for the CBTH group and 52.78 (SD = 11.65 years) for the control group.
• Patients had breast cancer stage 3 or lower.
• Karnofsky Performance Status (KPS) was 98.75 (SD = 3.19) in the CBTH group and 96.57 (SD = 7.45) in the control group.

• Type1
• Single site
• Urban radiation oncology clinic

The study was a randomized, clinical trial using a repeated measures design.

• Weekly fatigue was measured using the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue Subscale (FS)
• Daily levels of fatigue were measured using a 100-mm visual analog scale (VAS). 
• Possible covariates were neuroticism, measured using the NEO-Five Factor Inventory Neuroticism Subscale (NEO-N) shortened form self-report questionnaire; the second covariate was history of chemotherapy, assessed via medical record review and scored as yes or no.

Among the control group, weekly FSs increased over time at a rate of 1.57 points/week (p < 0.001). Over the course of radiotherapy, individuals in the intervention group had little increase in FS fatigue (0.6 points/week) (p = 0.01).

An intervention combining CBT and hypnosis was effective for controlling fatigue in patients with breast cancer undergoing radiotherapy, independent of neuroticism or past chemotherapy.

• The study had a small sample size, with less than 100 patients.
• The study lacked a sufficient attentional control.

Replication of the intervention effects should be studied in a larger population with appropriate attentional control procedures.