Therapeutic Touch and Stereotactic Breast Biopsy

Abstract & Commentary

By Donal P. O'Mathuna, PhD. Dr. O'Mathuna is a lecturer in Health Care Ethics, School of Nursing, Dublin City University, Ireland; he reports no financial relationship relevant to this field of study.

Source: Frank LS, et al. Does therapeutic touch ease the discomfort or distress of patients undergoing stereotactic core breast biopsy? A randomized clinical trial. Pain Med. 2007;8:419-424.

The objective of this trial was to determine whether therapeutic touch administered at the time of stereotactic core biopsy of suspicious breast lesions results in a reduction in anxiety and pain. The design of the trial was a randomized, patient-blinded, controlled trial of either Krieger-Kunz therapeutic touch administered by a trained practitioner or a sham intervention, mimicking therapeutic touch delivered during core biopsy. Trial participants were women with mammographically detected, nonpalpable breast lesions requiring biopsy in a stereotactic breast biopsy unit of a comprehensive breast center. Outcome measures included changes in pain and anxiety measured by visual analog scales immediately before and after stereotactic core biopsy. A total of 82 patients were accrued: 42 received actual therapeutic touch and 40 sham therapeutic touch. No significant differences were found between the arms for age, ethnicity, educational background, or other demographic data. The sham arm had a preponderance of left breast biopsies (48% vs 58%; P = 0.07) and received a slightly higher volume of epinephrine-containing local anesthetic (6.5 ± 6.1 vs 4.5 ± 4.5 mL; P = 0.09). Therapeutic touch patients were more likely to have an upper breast lesion location (57% vs 53%; P = 0.022).

No significant differences between the arms were seen regarding postbiopsy pain (P = 0.95), anxiety (P = 0.66), fearfulness, or physiological parameters. Similarly, no differences were seen between the arms when change in parameters from prebiopsy to postbiopsy was considered for any of the psychological or physiological variables measured. These findings persisted when confounding variables were controlled for.

Women undergoing stereotactic core breast biopsy received no significant benefit from therapeutic touch administered during the procedure. Therapeutic touch cannot be routinely recommended for patients in this setting.

Commentary

Reduced mortality from breast cancer begins with earlier and more accurate diagnosis. Current screening strategies are based on annual breast mammography, followed by further testing of any abnormalities detected. Stereotactic core biopsy (SCB) is a method of biopsying relatively small abnormalities that do not have a palpable lesion. A very small incision is made to the breast, and a biopsy needle collects a number of samples guided by mammography. Local anesthesia is used to minimize pain, although some discomfort and pain can still occur. The procedure itself can cause anxiety and fear, compounded by concerns about the results themselves. Women undergoing SCB could, therefore, benefit from therapeutic touch, given claims that this complementary therapy effectively relieves pain and reduces anxiety. The lack of physical contact is a further benefit.

Therapeutic touch (TT) was developed in the 1970s by Dolores Krieger, a nursing professor at New York University, and Dora Kunz, then President of the Theosophical Society in America. TT is based on the presumed existence of a non-physical "life energy" that permeates the universe and underpins human health and well-being.1 Therapists move their hands a few inches over clients' bodies to direct or modulate this energy to bring relaxation or healing. No physical contact is necessary, with the therapist's conscious intent to help being crucial. A sham procedure has been developed to provide a control intervention for clinical trials. This involves similar hand movements without the therapist's conscious intent to help created by having the therapist count backwards silently by sevens.

The randomized, controlled trial by Frank and colleagues was rigorously designed. Adequate randomization was described clearly, and patients, clinical staff, and research coordinators were blinded to intervention assignment. A power calculation was carried out which determined that 50 participants per arm were necessary to detect a 10-mm difference on the visual analog scales. A blinded analysis was planned after 80 patients were accrued to check the statistical assumptions. This showed "an unexpectedly small difference...between the study arms," and the remaining patients were not recruited. TT provided no additional benefit beyond placebo for pain, or physiological or psychological measures of anxiety or fearfulness. A number of confounding variables were tested to see if they interfered with the findings. The results were the same when these factors were controlled for.

These findings are in keeping with those of systematic reviews of the research on TT. Some studies have had positive findings, but these have often not been presented in the context of broader reviews of all the evidence.2 For example, Meehan conducted much of the early research on TT and pain, but in a review stated "that TT does not have a significant direct effect on postoperative pain and does not potentiate the short-term effect of narcotic analgesic."3 A Cochrane systematic review of TT for healing acute wounds found no evidence of benefit.4 Another Cochrane review of TT for anxiety disorders found no randomized or quasi-randomized, controlled studies in the area.5 Two meta-analyses found some moderate benefits from TT, but were highly critical of the quality of the research.6,7 Given this, "and missing information in published studies, it is impossible to make substantiative claims about the TT research base from this initial meta-analytic review."6

Given such conclusions from systematic reviews, use of TT as a distinct complementary therapy is not supported by high-quality evidence. Some research shows that patients report improvements after receiving TT. However, as in this study by Frank et al, similar benefits are usually found in the control group. Therefore, "it cannot be claimed with any confidence that TT is significantly more effective than a placebo."3 Promoting the specific methods or esoteric presuppositions of TT remains unsupported by research evidence.

References

1. Krieger D. Accepting your power to heal: The personal practice of therapeutic touch. Santa Fe, NM: Bear & Company; 1993.

2. O'Mathúna DP. Evidence-based practice and reviews of therapeutic touch. J Nurs Scholarship. 2000;32:279-285.

3. Meehan TC. Therapeutic touch as a nursing intervention. J Adv Nurs. 1998;28:117-125.

4. O'Mathúna DP, Ashford RL. Therapeutic touch for healing acute wounds. Cochrane Database Syst Rev 2003; Issue 4.

5. Robinson J, et al. Therapeutic touch for anxiety disorders. Cochrane Database Syst Rev 2007; Issue 3.

6. Peters RM. The effectiveness of therapeutic touch: A meta-analytic review. Nurs Sci Quart. 1999;12:52-61.

7. Winstead-Fry P, Kijek J. An integrative review and meta-analysis of therapeutic touch research. Altern Ther Health Med. 1999;5:58-67.