NCT07887035

Brief Summary

The aim of this clinical trial was to determine whether Reiki administered to patients after bariatric surgery reduced abdominal distension, nausea and vomiting, and pain severity, and improved their comfort levels. The primary research questions were as follows: Does Reiki reduce abdominal distension, nausea and vomiting, and pain severity? Does Reiki improve patient comfort? The researchers compared Reiki with sham Reiki (a procedure designed to resemble Reiki) and routine care. Seventy-five patients were assigned to one of the three groups using stratified randomization according to age and sex. Participants: For three days after bariatric surgery, participants received one session of Reiki, one session of sham Reiki, or routine care and completed questionnaires assessing abdominal distension, nausea and vomiting, pain, and comfort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

5 months

First QC Date

October 15, 2026

Last Update Submit

October 15, 2026

Conditions

Keywords

Nauseavomittingdistensionpaincomfortbariatric surgerycarereiki

Outcome Measures

Primary Outcomes (4)

  • Nausea and Vomitting

    Nausea was assessed using the Rhodes Index of Nausea, Vomiting, and Retching (INVR). The maximum possible score is 32, with higher scores indicating more severe nausea, vomiting, and retching symptoms.

    Before Reiki administration and on postoperative days 0, 1, and 2. On the evening of discharge, the scale was administered by telephone on postoperative day 3.

  • Pain

    The Numerical Rating Scale (NRS) was used to assess pain intensity. Participants were informed that "0" represented "no pain at all," that pain intensity increased as the numbers increased, and that "10" represented "unbearable pain." They were then asked to select the number that best represented their pain intensity.

    Twice daily (before and after the intervention) for three postoperative days.

  • Distension

    The Numerical Rating Scale (NRS) was used to assess abdominal distension. Participants were informed that "0" represented "no abdominal distension," that the severity of abdominal distension increased as the numbers increased, and that "10" represented "the most severe abdominal distension imaginable." They were then asked to select the number that best represented their perceived level of abdominal distension.

    Twice daily (before and after the intervention) for three postoperative days.

  • Comfort

    Patient comfort was assessed using the General Comfort Questionnaire (GCQ). The maximum possible total score is 192, and the minimum is 48.

    Twice daily (before and after the intervention) for three postoperative days.

Study Arms (3)

Reiki group

EXPERIMENTAL

Reiki Group participants who underwent bariatric surgery received a 30-minute Level 1 Reiki session administered by a researcher trained and experienced in the Usui method, four hours after analgesic administration.

Other: reiki

Sham reiki

PLACEBO COMPARATOR

Sham Reiki Group participants who underwent bariatric surgery received a single 30-minute sham Reiki session four hours after analgesic administration. The session was administered by an individual who had not received Reiki training or Reiki attunement. The procedure was presented to participants as Reiki.

Other: Sham Reiki

Control

NO INTERVENTION

Routine care

Interventions

reikiOTHER

Participants received a single 25-30-minute Level 1 Reiki session targeting nine specific areas of the body. The session was conducted four hours after analgesic administration following bariatric surgery by a researcher who had received Reiki attunement, in accordance with the study protocol.

Reiki group

Sham Reiki in addition to routine care, participants received a 25-30-minute sham Reiki session targeting nine specific areas of the body, administered four hours after analgesic administration following bariatric surgery. In accordance with the study protocol, the session was conducted by Interviewer 2, who had not received Reiki training.

Sham reiki

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent laparoscopic bariatric surgery (sleeve gastrectomy).
  • Aged 18 years or older.
  • No visual or hearing impairments.
  • Able to speak Turkish and communicate verbally.
  • Body mass index (BMI) ≥ 35 kg/m².
  • At least four hours had elapsed since the last analgesic administration.
  • No diagnosed psychiatric disorders.
  • Pain intensity score of ≥ 3 on the Numerical Rating Scale (NRS) in each group.
  • Patients transferred to the postoperative ward.
  • Willingness to participate in the study.

You may not qualify if:

  • Patients taking psychiatric medications.
  • Patients with open wounds.
  • Patients with cardiac arrhythmias.
  • Patients with a pacemaker.
  • Patients with chronic pain who were taking opioid medications.
  • Patients who practiced or taught Reiki.
  • Patients who had received training in energy therapies (e.g., Reiki or Therapeutic Touch).
  • Patients using another complementary and integrative therapy (CIT) modality.
  • Patients whose surgery lasted longer than 2 hours.
  • Patients who spent postoperative day 0 in the intensive care unit.
  • Patients who underwent revision surgery.
  • Individuals who participated in the pilot study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana City Training and Research Hospital

Adana, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

NauseaDilatation, PathologicPain

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Outcomes Assessor) Participants in the Reiki and sham Reiki groups were unaware of which procedure they received. Participants in the routine care group did not observe the other procedures. Interviewer 1, who administered the questionnaires, was unaware of group assignments during outcome assessment. The Reiki practitioner and Interviewer 2, who administered sham Reiki, knew which procedures they delivered. The statistician analyzed data labeled with group codes without knowing what the codes represented. A stratified block randomization method based on age and sex was used to ensure comparability between groups. A previous randomized controlled trial involving patients undergoing bariatric surgery reported that women accounted for 82.0% and 78.2% of the intervention and control groups, respectively. Based on these findings, a female-dominant allocation ratio of 9:1 was used in the present study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

October 15, 2026

First Posted

October 21, 2026

Study Start

November 1, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

October 21, 2026

Record last verified: 2026-10

Locations