Objectives

To evaluate whether or not healing [by the laying-on of hands or by distant healing], in addition to conventional therapies, can enhance recuperation from [medical or surgical problem]

Methods

Clinical staff will obtain the permission of patients who are undergoing conventional therapy for [medical or surgical problem] to be included in a controlled study of healing.

Patients will be informed that they may or may not receive treatment after their agreement. This will provide a comparison between those who receive healing and those who do not, in order to assess whether healing in fact produces significant effects.

Laying-on of hands treatment will be arranged to the mutual convenience of patients, healers and research staff.

Distant healing will be arranged on a double blind basis. A research assistant will contact a healer for each distant healing patient, informing him/her of the name and town of residence of patients and of the problem to be treated. Healers will send healing during the course of the patients' treatment and/or recuperation.

Healers will record dates and times of healings and any impressions obtained during the healings.

Clinical staff who assess patients' progress will be blind as to who is receiving healing, either by laying-on of hands or by distant healing.

Criteria for inclusion/exclusion in the study will be decided between clinical staff, healers, and researchers.

Patients will be assigned randomly to the healing or non-healing groups, according to numbers in a random number system, matched to their successive referral for the study.

A minimum of ["X"] patients will be included in each group. (Early consultation with statistician is strongly advised.)

Measurements

Each treating physician will record relevant information on a research assessment sheet to be agreed and prepared prior to the clinical study.

Possible parameters for study could include (e.g. in a study of healing for surgery and post-surgical recovery):

• Pain, per visual analogue scale, validated pain assessment scales
• Anxiety, per visual analogue scale and/ or validated anxiety assessment scales
• Doses of medication required (e.g. for pain, post-operatively)
• Hours till urinating and moving bowels (post-operatively)
• Hours till ambulating (post-operatively)
• Hours with post-operative fever
• Laboratory studies before and after surgery
• Untoward events in hospital, to include worsening of presenting condition, negative treatment effects
• Days till discharge from hospital- Subjective reports of improvement will be solicited, in open-ended questions and a validated questionnaire.

Problems suitable for study (BY NO MEANS AN EXCLUSIVE LIST!):

Arthritis, backache, burns, cancer (pain, malaise, side effects of radio- and chemotherapy), early and/or complicated labor, fractures, irritable bowel syndrome, multiple sclerosis, pain (e.g. chronic herpes, migraines, tension headaches, irritable bowel syndrome), surgical interventions (e.g. cholecystectomy, hip replacement).

Data

Methods for collecting data should be specified.

Statistical analyses

Numbers of subjects required to achieve the minimal criteria for accepting the results as being beyond chance level must be decided.

Consultation with a professional statistician is essential. There are many variables that influence which statistical methods will be relevant. Methods to be used should be specified prior to commencing the study.

Research Board approval for the study must be obtained

Institutional Review Boards have protocols for protection of patients' rights. Research proposals must have this approval.

In some studies of prayer healing this has been omitted because there is no tangible, directly demonstrable intervention. Most healers consider it unethical to send healing to anyone who has not agreed that healing should be sent.

RCTs in animals, plants, other organisms

Randomized controlled studies in animals, plants and other organisms are much easier to run because extraneous variables are easier to control.

The simplest model is with plants. Fill pots of the same size with soil from the same source. Use larger seeds so that you can control both the placing of the seed (e.g. sharp end of corn seed pointing down, so roots of all specimens grow straight down) and the depth of the seed in the earth. Water the various pots with measured amounts of water from the same source. Provide equal lighting for all pots.

Have a person who does not know the assignments of the pots (for healing vs controls) handle the pots from beginning to end.

Have a person who does not know the assignments of the pots measure the plants at the pre-determined endpoint(s).

Plant studies are easy for inexperienced researchers to do.

Animal studies are much more complex and dependent on the specific species, types of problems being studied.