The Effect of Guided Imagery in Laparoscopic Cholecystectomy

NCT07860385 | Completed DMC

• 1 other identifier: E-30785963-020-266590 / B.416
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial examines the effects of guided imagery in adults recovering from laparoscopic gallbladder surgery. The study focuses on pain levels, vital signs, and the quality of recovery after surgery. The study addresses the following questions:

• Do participants who receive guided imagery experience different levels of pain after surgery?
• Do participants' vital signs change after guided imagery?
• Does the quality of recovery differ between participants who receive guided imagery and those who do not? Participants are followed in two groups. One group receives an 18-minute guided imagery session in addition to standard care, while the other group receives standard care only. The results from the two groups are compared to assess the possible effects of guided imagery. During the study, participants' pain levels and vital signs are measured at planned time points. Their quality of recovery after surgery is also assessed.

Conditions

Laparoscopic Cholecystectomy

Keywords

vital signs; Laparoscopic cholecystectomy; pain; guided imaging; quality of recovery

Outcome Measures

Primary Outcomes (8)

• Change in Postoperative Pain Intensity

  Pain intensity will be assessed using the Numeric Pain Scale (NPS).Participants will rate their pain on a scale from 0 to 10, with higher scores indicating greater pain intensity.

  Before the guided imagery intervention and approximately 30 minutes after the intervention.

• Change in Postoperative Quality of Recovery

  Quality of recovery will be assessed using the 40-item Quality of Recovery Questionnaire (QoR-40). The total score ranges from 40 to 200, with higher scores indicating better quality of recovery.

  At baseline and 24 hours after surgery.

• Change in Heart Rate

  Heart rate will be measured in beats per minute (beats/minute).

  At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.

• Change in Respiratory Rate

  Respiratory rate will be measured in breaths per minute (breaths/minute).

  At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.

• Change in Systolic Blood Pressure

  Systolic blood pressure will be measured in millimeters of mercury (mmHg).

  At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.

• Change in Diastolic Blood Pressure

  Diastolic blood pressure will be measured in millimeters of mercury (mmHg).

  At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.

• Change in Oxygen Saturation

  Oxygen saturation will be measured as a percentage (%).

  At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.

• Change in Body Temperature

  Body temperature will be measured in degrees Celsius (°C).

  At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.

Study Arms (2)

Control Grup

NO INTERVENTION

At baseline, participant characteristics were recorded, vital signs were measured, and pain intensity and quality of recovery were assessed. Participants continued to receive standard clinical care, with no additional study-specific intervention. Approximately half an hour after the initial assessment, pain intensity and vital signs were measured again. On the day following surgery, vital signs and quality of recovery were reassessed.

Guided Imagery Grup

EXPERIMENTAL

Participants who met the eligibility criteria and agreed to take part in the study were informed about the study procedures, and their consent was obtained. Before the intervention, participant characteristics were recorded, vital signs were measured, and pain intensity and quality of recovery were assessed. Participants then received a guided imagery session lasting approximately 18 minutes. About half an hour after the session, pain intensity and vital signs were reassessed. On the day following surgery, vital signs and quality of recovery were evaluated again.

Behavioral: Guided Imagery

Interventions

Guided Imagery BEHAVIORAL

Guided imagery is a mind-body approach that encourages individuals to create calming and positive mental images. During the practice, verbal guidance, music, nature sounds, or visual cues may be used to help individuals imagine themselves in a peaceful, safe, and comfortable setting. The main purpose of guided imagery is to promote relaxation by shifting attention away from unpleasant experiences such as pain, stress, or anxiety. It can be used as a non-pharmacological complementary approach alongside standard medical treatment and care.

Guided Imagery Grup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years of age or older,
• Being able to communicate effectively and cooperate with the study procedures,
• Agreeing to participate in the study voluntarily,
• Receiving postoperative care under the standard analgesic treatment protocol.

You may not qualify if:

• Having speech, hearing, or neurological impairments that could interfere with participation in the study assessments,
• Being unable or unwilling to participate in the guided imagery intervention.

Sponsors & Collaborators

• Malatya Turgut Ozal University: lead

Study Sites (1)

Malatya Training and Research Hospital

Malatya, Turkey (Türkiye)

Location

Related Publications (4)

• Alvarez-Garcia C, Yaban ZS. The effects of preoperative guided imagery interventions on preoperative anxiety and postoperative pain: A meta-analysis. Complement Ther Clin Pract. 2020 Feb;38:101077. doi: 10.1016/j.ctcp.2019.101077. Epub 2019 Dec 4.

  PMID: 32056813 BACKGROUND

• Zengin Aydin L, Dogan A. The Effect of Guided Imagery on Postoperative Pain Management in Patients Undergoing Lower Extremity Surgical Operations: A Randomized Controlled Trial. Orthop Nurs. 2023 Mar-Apr 01;42(2):105-112. doi: 10.1097/NOR.0000000000000929.

  PMID: 36944205 BACKGROUND

• Lu YJ, Lee MC, Chen CY, Liang SY, Li YP, Chen HM. Effect of Guided Imagery Meditation During Laparoscopic Cholecystectomy on Reducing Anxiety: A Randomized Controlled Trial. Pain Manag Nurs. 2022 Dec;23(6):885-892. doi: 10.1016/j.pmn.2022.07.003. Epub 2022 Jul 31.

  PMID: 35922271 BACKGROUND

• Patricolo GE, LaVoie A, Slavin B, Richards NL, Jagow D, Armstrong K. Beneficial Effects of Guided Imagery or Clinical Massage on the Status of Patients in a Progressive Care Unit. Crit Care Nurse. 2017 Feb;37(1):62-69. doi: 10.4037/ccn2017282.

  PMID: 28148616 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gurkan Kapikiran, Assoc. Prof. Dr.

  Malatya Turgut Ozal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Group 1 Participants who met the eligibility criteria and agreed to take part in the study were informed about the study procedures, and their consent was obtained. Before the intervention, participant characteristics were recorded, vital signs were measured, and pain intensity and quality of recovery were assessed. Participants then received a guided imagery session lasting approximately 18 minutes. About half an hour after the session, pain intensity and vital signs were reassessed. On the day following surgery, vital signs and quality of recovery were evaluated again. Group 2 At baseline, participant characteristics were recorded, vital signs were measured, and pain intensity and quality of recovery were assessed. Participants continued to receive standard clinical care, with no additional study-specific intervention. Approximately half an hour after the initial assessment, pain intensity and vital signs were measured again. On the d

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: October 6, 2026
• Study Start: November 7, 2024
• Primary Completion: May 7, 2026
• Study Completion: July 7, 2026
• Last Updated: October 8, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)