The combined effects of reflexology massage and respiratory relaxation on pain: yet another case of scientific misconduct?

Removing the chest tube in cardiac patients after surgery is one of the worst experiences of hospitalization in the intensive care units. Various pharmacological and non-pharmacological methods are available to control pain in these patients. This study aimed to investigate the combined effect of reflexology massage and respiratory relaxation on pain following chest tube removal in cardiac surgery patients of Shahid Beheshti Hospital in Shiraz, Iran, in 2023.

The study was a double-blind randomized clinical trial performed on 140 patients who underwent heart surgery and had a chest tube in Shiraz, Iran. The samples were randomly divided into four groups:

1- control group,

2- respiratory relaxation group,

3- foot reflex massage group,

4- a combination of respiratory relaxation and reflexology massage.

To collect data, two demographic questionnaires, and a visual analog scale were used.

The participants of the 4 groups were not meaningfully different in terms of age, BMI, duration of surgical operation, gender, job, education, place of residency, number of chest tubes, history of operation (P = 0.99, 0.31, 0.06, 0.81, 0.97, 0.96, 0.17, 0.10, 0.89 respectively).

The mean scores of pain intensity during chest tube removal, and 15 min after chest tube removal were not statistically different among the 4 groups. However, just after chest tube removal, the mean scores of pain intensity differed meaningfully among four groups (P = 0.008).

The authors concluded that the results showed that reflexology massage and respiratory relaxation both reduce pain immediately after chest tube removal in heart surgery patients. Also, the combination of these two techniques was more effective in reducing patients’ average pain.

Double blind?

Really?

How did they do that?

Here is their description:

“For the blinding purpose of the study, a nurse who worked at the ICU had to record the pain intensity and the data, so the possible researcher bias did not impact the results. Also, the patients knew the concept of the study but did not know that there were whether in single relaxation groups or mixed methods groups and did not know that other patients had different methods used for them. Also, the pain intensity data for the control group was routinely checked by the nurses, and along with the fact that they had no information that some of the patients were in the intervention groups and received complementary and alternative therapies, therefore, their data were also considered blinded. Therefore, the study could have their initial aim to use the double-blinded design.”

Double blind usually means that the therapist and the patient were masked as to the group alloca. Blinding the nurse is fine, but the therapists were not blind and could therefore have influenced the patients via verbal and non-verbal communications.

According to the authors, patients did not know whether they were “in single relaxation groups or mixed methods groups”. I think that cannot be true. Even if it were, what about the control group? Surely every patient knows whether or not he/she receives a reflexology massage!

It follows, I think, that the study was NOT double-blind, not even single-blind!

Does that matter?

Yes!

Firstly, I don’t want to be misled in this way.

Secondly, as blinding did not happern, the findings can be explaind by the effects of patient expectation and might therefore NOT be the result of the therapies. In other words, the conclusions drawn by the authors are not warranted.