eFigure. Illustration of Conditions for the 3 Study Groups
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Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018;154(9):1045–1049. doi:10.1001/jamadermatol.2018.1783
Can the use of a stress ball or hand-holding reduce anxiety during surgery performed with the patient under local anesthesia?
This randomized clinical trial of 135 patients found that anxiety decreased for all patients after surgery began but that patients given a stress ball or whose hands were held were not less anxious than other patients (treatment as usual). In addition, patients who used stress balls and whose hands were held did not experience less pain and were no more satisfied than others.
In general, neither stress ball use nor hand-holding appears to reduce patient anxiety during skin surgery while awake; some people may benefit from these methods even if most do not.
Patients undergoing skin surgery under local anesthesia can experience anxiety. Adjuvant intraoperative anxiety reduction methods may help.
To assess whether hand-holding or holding a stress ball reduces patient anxiety during excisional surgery of head or neck skin cancer with the patient under local anesthesia and to measure pain and patient satisfaction.
Design, Setting, and Participants
In this nonblinded, single-center randomized clinical trial, performed from January 24 through April 26, 2017, at a dermatology outpatient service in an urban, academic medical center, a consecutive sample of 135 adults who required excisional removal of nonmelanoma skin cancer of the head or neck was randomized and studied.
Participants were randomized 1:1:1 to 3 groups: hand-holding, stress ball, or control (treatment as usual). Participants in the hand-holding group had a female researcher hold one of their hands during administration of anesthesia and extirpation, and those in the stress ball group held a round compressible ball and squeezed it as desired during the same period.
Main Outcomes and Measures
The primary outcome was anxiety, measured by a visual analog scale (VAS), 6-item State Trait Anxiety Inventory (STAI), and physiologic measures (blood pressure and heart rate). Secondary outcomes were pain during the procedure and overall participant satisfaction. In addition, participants were asked how many hours they spent researching the procedure before surgery.
A total of 135 participants, 45 per study arm, were enrolled (mean [SD] age, 65.5 [13.9] years; 84 [62.2%] male; 134 [99.3%] white). There were no withdrawals or dropouts. Anxiety decreased over time in all groups, but no significant differences were found in the 3 anxiety measures across the 3 groups (VAS anxiety score before: control group, 3.11; hand-holding group, 3.04; stress ball group, 3.09 [P > .99]; VAS anxiety score during: control group, 1.89; hand-holding group, 2.31; stress ball group, 2.47 [P = .55]; STAI score: control group, 8.91; hand-holding group, 8.93; stress ball group, 8.76 [P = .96]). The 3 groups also did not significantly differ in postprocedure pain scores (control group, 0.78; hand-holding group, 0.64; stress ball group, 0.67; P = .85). Almost all participants (134 [99.2%]) were very satisfied. Participants who had done research had higher preoperative VAS anxiety scores (researched, 3.84; did not research, 2.62; P = .04).
Conclusions and Relevance
Hand-holding and squeezing a stress ball do not appear to provide incremental anxiety reduction in patients during excisional skin cancer surgery. It is possible that some subgroups may respond better or that patients may respond better when able to select and tailor their preferred anxiety reduction method.
ClinicalTrials.gov identifier: NCT02816996
Dermatologic surgery differs from many other surgical specialties in that most skin procedures, including skin cancer excisions, are performed with the patient under local anesthesia. Because patients are alert and awake intraoperatively, they can experience anxiety. Specifically, patients may worry about the sight of blood, prospect of procedure-associated pain, and disfigurement coincident with future wound healing.
Previous studies1,2 in other fields, such as cataract surgery and percutaneous vertebroplasty, have found that hand-holding by nurses can diminish anxiety during local anesthetic procedures. A study3 of minimally invasive venous surgery found that intraoperative anxiety and pain ratings were lower in the group that used stress balls as a distraction technique compared with treatment as usual. In dermatologic surgery and skin cancer excisions, various relaxation strategies, such as patient-selected music, hypnosis, and self-guided imagery, have been suggested and investigated.4-7 To our knowledge, no previous studies have evaluated the methods of hand-holding and stress ball use in the field of dermatologic surgery.
The aim of this randomized clinical trial was to assess whether hand-holding or holding a stress ball reduces patient anxiety during excisional removal of nonmelanoma skin cancer under local anesthesia. In addition, associated pain, physiologic correlates of anxiety, and patient satisfaction were measured.
We conducted a nonblinded, single-center randomized clinical trial. From January 24 to April 26, 2017, a total of 135 participants were randomized 1:1:1 to 1 of 3 groups with 45 patients in each group: hand-holding, stress ball use, or control (treatment as usual). There were no withdrawals or dropouts, and all patients were included in the analysis. No changes were made to the trial after commencement. The trial protocol can be found in Supplement 1. The Figure shows the number of participants at the stages of enrollment, allocation, follow-up, and analysis. The study was approved by the Northwestern University Institutional Review Board. Written informed consent was obtained from the study participants before the start of the procedure. All data were deidentified.
Patients older than 18 years undergoing skin cancer excision of the head or neck were eligible. Patients were excluded if they had a history of wound healing problems. Patients self-reported race and ethnicity, with options defined by the investigator. Race and ethnicity were assessed in the study to characterize the population undergoing Mohs surgery. All procedures were performed by 1 male surgeon (M.A.) in the Department of Dermatology at Northwestern University in Chicago, Illinois.
Participants in the hand-holding group had a female researcher (A.W., K.C.F.) hold one of their hands during the administration of local anesthesia and surgical removal of the tumor. The researcher’s fingers were closed, not interlocked, and her hand was placed on top of the participant’s hand. The researcher kept her hand still without tapping or rubbing. In addition, the researcher did not wear gloves. The hand-holding group conditions are depicted in eFigure, A, in Supplement 2.
Participants randomized to the stress ball group were given a black, round compressible ball (referred to as a squeeze ball in addressing the patient to avoid implying that the procedure was inherently stressful) during anesthesia and excision and were able to squeeze the ball as frequently as desired. The stress ball group conditions are depicted in eFigure, B, in Supplement 2.
Participants in the control group had treatment as usual and did not have their hands held or receive a stress ball. The surgical team only touched the participant to the extent necessary to perform the procedure. The control group conditions are depicted in eFigure, C, in Supplement 2.
The primary outcome for this study was reduction in anxiety. Anxiety was measured using 3 approaches: a visual analog scale (VAS), the 6-item State Trait Anxiety Inventory (STAI), and physiologic measures (blood pressure and heart rate). The VAS was a 10-cm line ranging from no anxiety at all to extremely anxious. Participants placed a mark on the VAS before surgery. Immediately after the surgical excision and before closure of the defect, participants were again asked to rate the level of anxiety that they felt. The 6-Item STAI was a measure of anxiety that has been used in fast-paced clinical settings to assess participant anxiety8 and is derived from the 20-item STAI, which evaluates state anxiety related to present circumstances and trait anxiety related to an individual’s personality characteristics. Scores ranged from 6 (least anxious) to 24 (most anxious). Participants completed the STAI immediately after the procedure. Physiologic measures were taken before and after the procedure.
The secondary outcomes for this study were pain during the procedure and overall participant satisfaction with the procedure. Pain was measured after the procedure with a VAS, ranging from no pain at all to worst possible pain. Participant satisfaction was assessed with a Likert scale of 1 to 5, ranging from very dissatisfied to very satisfied. In addition, participants were asked how many hours they spent researching the procedure before their excision to evaluate whether research time correlated with anxiety levels. No changes were made to trial outcomes after the trial commenced.
Sample size was determined to be 135 participants. Using 1-way analysis of variance (ANOVA) to assess the differences, an SD of 10 and a sample size of 41 participants per group for a total of 123 has 81% power to detect a 4-unit mean difference in scale scores across the 3 groups. A sample size of 45 participants per group for a total of 135 has 85% power to detect a 4-unit mean difference in scale scores. A 2-sided test and type I error rate of 5% were assumed.
Participants were randomized using a computer randomization program (SAS software, version 9.4; SAS Institute Inc). A researcher (E.P.) in the Department of Dermatology at Northwestern University was responsible for enrolling the participants, using the randomization software, and assigning participants to interventions.
Because of the nature of the intervention, the participants and surgeon were unable to be masked. The individuals measuring the VAS scores were masked to the participant groups.
Scores on the STAI, VAS for anxiety, VAS for pain, and patient satisfaction measure were analyzed using 1-way ANOVA to assess the differences among the 3 treatment groups. Time spent researching the procedure was described using descriptive analysis. Paired, 2-taied t tests were used to compare any VAS anxiety scores before and during the procedure for each treatment. Subanalyses were conducted to determine whether sex or previous excisional surgery modified the effect of hand-holding or anxiety using 1-way ANOVA.
A total of 135 patients (mean [SD] age, 65.5 [13.9] years; 84 [62.2%] male; 134 [99.3%] white) were randomized and included in the analysis. Participant characteristics and anatomical location of the excisional procedure are given in Table 1.
All groups experienced a nominal decrease in anxiety from before to during the procedure as measured by the VAS, with statistically significant decreases in the control (3.11 before and 1.88 after, P = .003) and hand-holding groups (3.04 before and 2.31 after, P = .03) and without statistical significance in the stress ball group (3.09 before and 2.47 after, P = .07). The VAS scores were comparable among the groups before (control group, 3.11; hand-holding group, 3.04; stress ball group, 3.09; P > .99) and during (control group, 1.89; hand-holding group, 2.31; stress ball group, 2.47; P = .55) the procedure. No treatment effect was identified for the anxiety VAS after stratification by sex or history of Mohs surgery. The STAI scores after the procedure were also comparable among the groups (hand-holding group, 8.93; stress ball group, 8.76; control group, 8.91; P = .96). Physiologic measures did not change from before to after the procedure, and no significant differences were found in these measures among the 3 study arms (Table 2).
With regard to secondary outcomes, the 3 groups did not significantly differ in postprocedure pain (control group, 0.77; hand-holding group, 0.64; stress ball group, 0.67; P = .85). In addition, participant satisfaction was not affected by either active intervention, with 134 participants (99.2%) responding 5 of 5 on the Likert scale (very satisfied).
With regard to patients’ prior research on the procedure, 51 participants (37.8%) reported having researched the procedure before coming to the office. Participants who had researched had significantly increased levels of anxiety measured by the VAS before the procedure than those who did not (researched, 3.84; did not research, 2.62; P = .04), without a significant difference during the procedure (researched, 2.76; did not research, 1.89; P = .06). Women were more likely to research (27 women [52.9%] vs 24 men [28.6%]) and had higher VAS anxiety levels. The percentage of patients researching Mohs surgery before the procedure was lower than anticipated, which may be a result of thorough explanations of the procedure provided by referring dermatologists before surgery. In addition, 57 patients (42.2%) had previously undergone a Mohs procedure and were familiar with the process. There were no adverse effects or harm to any of the participants in the study as a result of the interventions.
This study found that low-risk, noninvasive, and low-cost methods, such as hand-holding or stress ball squeezing, can be implemented during head and neck skin cancer excision. On the basis of our results, these methods did not differ from each other or the control condition in their ability to reduce intraoperative anxiety. All participants had a decrease in anxiety during their procedure.
Many patients commented anecdotally on the calming effect of hand-holding or stress ball use. In this context, it was surprising that the total data did not show these interventions to preferentially decrease anxiety or alleviate pain. Several explanations are possible. First, a subgroup of patients who are very anxious at baseline may benefit from such interventions, but other groups may feel unwilling to admit to anxiety or find it uncomfortable or too intimate to have their hands held. Although our study was adequately powered for the primary outcome, power may have been insufficient to detect subgroup differences. Second, the interventions being studied may be valuable, but the concurrent implementation of other routine standard-of-care methods of reducing anxiety may have limited their incremental utility. To make patients comfortable, it is common to ensure that they have an opportunity to ask questions, are comfortable with positional aids (eg, pillows), are suitably warm, have been provided refreshments if desired, are conversed with reassuringly during the procedure, are given clear postoperative instructions orally and in writing, and are allowed to rest before they go home. Cumulatively, these measures may reduce patient anxiety as low as possible, and additional interventions, such as stress ball use and hand-holding, may not reduce anxiety further. However, it is not appropriate or ethical to deliberately mistreat patients and make them anxious to detect the effect of an anxiety reduction intervention.
Proceeding from this logic, it seems that hand-holding and stress balls may still provide stress relief in patients who are particularly anxious before the procedure or are comforted by human touch. One method to potentially optimize the value of hand-holding could entail recruiting a family member or friend instead of an unfamiliar member of the medical team. Alternatively, patient preference could be taken into account by providing patients with a menu of anxiety reduction methods from which they could select. For instance, anxious patients might opt for a stress ball in one hand while having their other hand held, whereas patients who preferred to listen to music might decline both and keep their hands by their side. Allowing the patients to choose may also improve their experience by providing them an element of control during their procedure.
Limitations in the study design may have affected the results. Although patients were randomized and allocation was balanced to each of the 3 study arms, because of the nature of the interventions, participants could not be masked. Although validated patient-reported measures for anxiety were used, assessing VAS anxiety levels before surgery may have drawn patient attention and affected their reported anxiety levels, serving as a potential intervention in itself. In addition, elements that are also known to be related to patient-reported anxiety (eg, talking to nurses during surgery) were not accounted for, and no attempt to standardize these confounding factors or evaluate their effect was made. The procedure being cancer related may have affected patient anxiety to a degree. Of note, the very high overall patient satisfaction rate may have been affected by a desire to please the attending physician. Alternatively, patients may have appreciated the effort to reduce their anxiety, which may have contributed to their satisfaction with the surgery.
Additional studies may explore the significantly heightened anxiety observed in the participants who researched the procedure before the day of surgery. Providing patients with reassuring preoperative informational materials may help counter the alarming images available on the internet. It is also possible that those who are more anxious at baseline are more inclined to research their health. Larger sample sizes may also enable subgroup analyses to better understand which types of patients most benefit from anxiety reduction intervention.
Overall, this study did not find an incremental, cohort-wide reduction in patient anxiety associated with hand-holding or stress ball use during excisional procedures of the head or neck. It is possible that a subgroup of patients may benefit, particularly if allowed to choose their preferred method.
Accepted for Publication: April 30, 2018.
Corresponding Author: Murad Alam, MD, MSCI, MBA, Department of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N St Clair St, Ste 1600, Chicago, IL 60611 (email@example.com).
Published Online: July 18, 2018. doi:10.1001/jamadermatol.2018.1783
Author Contributions: Dr Alam had full access to the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Yanes, Poon, Alam.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Yanes, Alam.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Poon, Alam.
Obtained funding: Alam.
Administrative, technical, or material support: Poon.
Conflict of Interest Disclosures: Dr Alam reported serving as a consultant for Pulse Biosciences and as a principal investigator on studies funded in part by Regeneron. In all cases, grants and gifts in kind have been provided to Northwestern University and not Dr Alam directly, and Dr Alam has not received any salary support from these grants. No other disclosures were reported.
Funding/Support: This study was supported by Departmental Research Funds, Department of Dermatology, Northwestern University, and the Measurement of Priority Outcomes Variables in Dermatologic Surgery (IMPROVED) Group, which is partly funded by an unrestricted grant from Merz.
Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.