Laparoscopic CholecystectomyNCT07860385
The Effect of Guided Imagery in Laparoscopic Cholecystectomy
A study testing Guided Imagery in people with Laparoscopic Cholecystectomy, run by Malatya Turgut Ozal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Nov 2024to 7 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Malatya Training and Research Hospital
Malatya
About this study
Official title: The Effect of Guided Imagery on Pain, Vital Signs, Recovery Quality in Patients Laparoscopic Cholecystectomy
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:
Read more
- 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.
Read the detailed description
Pain is a common concern following laparoscopic cholecystectomy and may affect patients' postoperative recovery. Physiological responses associated with pain may lead to changes in vital signs and influence the recovery process. Therefore, evaluating non-pharmacological approaches that can be used alongside standard treatment and care is important.
Guided imagery is a mind-body practice that directs a person's attention toward calming images and thoughts. This study evaluates the effects of guided imagery on postoperative pain, vital signs, and quality of recovery in adults undergoing laparoscopic cholecystectomy.
The study is conducted as a randomized controlled trial with a pretest-posttest design. Participants are assigned to either the guided imagery group or the control group. Participants in the guided imagery group receive an 18-minute guided imagery session in addition to standard care. The session includes calming nature images, music, and verbal guidance. Participants in the control group receive standard clinical care without any additional intervention.
Pain levels, vital signs, and quality of recovery are assessed at baseline in both groups. Approximately 30 minutes after the guided imagery intervention, pain levels and vita
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Guided Imagery
- Keywords
- vital signs, Laparoscopic cholecystectomy, pain, guided imaging, quality of recovery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Guided Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline and 24 hours after surgery.
Change in Heart Rate
Heart rate will be measured in beats per minute (beats/minute).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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).
Measured: At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start7 Nov 2024
- Primary completion7 May 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malatya Turgut Ozal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurkan Kapikiran, Malatya Turgut Ozal University
- Investigators
- Gurkan Kapikiran, Assoc. Prof. Dr., Principal investigator, Malatya Turgut Ozal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860385
- Sponsor's protocol ID
- E-30785963-020-266590 / B.416
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: During the data collection process, participants were informed that their data would be kept confidential and would not be shared. Therefore, the individual participant data collected in this study will not be made publicly available.
Publications
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.
PubMed 32056813Zengin 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.
PubMed 36944205Lu 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.
PubMed 35922271Patricolo 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.
PubMed 28148616
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided Imagery on Pain, Vital Signs, Recovery Quality in Patients Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07860385
- Acronym / sponsor ID
- E-30785963-020-266590 / B.416
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- vital signs, Laparoscopic cholecystectomy, pain, guided imaging, quality of recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Malatya Turgut Ozal UniversityUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pain is a common concern following laparoscopic cholecystectomy and may affect patients' postoperative recovery. Physiological responses associated with pain may lead to changes in vital signs and influence the recovery process. Therefore, evaluating non-pharmacological approaches that can be used alongside standard treatment and care is important.
Guided imagery is a mind-body practice that directs a person's attention toward calming images and thoughts. This study evaluates the effects of guided imagery on postoperative pain, vital signs, and quality of recovery in adults undergoing laparoscopic cholecystectomy.
The study is conducted as a randomized controlled trial with a pretest-posttest design. Participants are assigned to either the guided imagery group or the control group. Participants in the guided imagery group receive an 18-minute guided imagery session in addition to standard care. The session includes calming nature images, music, and verbal guidance. Participants in the control group receive standard clinical care without any additional intervention.
Pain levels, vital signs, and quality of recovery are assessed at baseline in both groups. Approximately 30 minutes after the guided imagery intervention, pain levels and vita
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Guided ImageryParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided ImageryGuided 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. | Behavioural | Guided Imagery Grup |
Primary outcome
Change in Postoperative Pain Intensity
Time frame: Before the guided imagery intervention and approximately 30 minutes after the intervention.
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.
Change in Postoperative Quality of Recovery
Time frame: At baseline and 24 hours after surgery.
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.
Change in Heart Rate
Time frame: At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.
Heart rate will be measured in beats per minute (beats/minute).
Change in Respiratory Rate
Time frame: At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.
Respiratory rate will be measured in breaths per minute (breaths/minute).
Change in Systolic Blood Pressure
Time frame: At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.
Systolic blood pressure will be measured in millimeters of mercury (mmHg).
Change in Diastolic Blood Pressure
Time frame: At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.
Diastolic blood pressure will be measured in millimeters of mercury (mmHg).
Change in Oxygen Saturation
Time frame: At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.
Oxygen saturation will be measured as a percentage (%).
Change in Body Temperature
Time frame: At baseline, approximately 30 minutes after the intervention, and 24 hours after surgery.
Body temperature will be measured in degrees Celsius (°C).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 32056813Alvarez-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.
- Background: PubMed 36944205Zengin 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.
- Background: PubMed 35922271Lu 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.
- Background: PubMed 28148616Patricolo 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.
- Individual participant dataSharing planned: No. During the data collection process, participants were informed that their data would be kept confidential and would not be shared. Therefore, the individual participant data collected in this study will not be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gurkan Kapikiran, Assoc. Prof. Dr. principal investigator
Malatya Turgut Ozal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery in people with Laparoscopic Cholecystectomy, run by Malatya Turgut Ozal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postoperative Pain Intensity (time frame: Before the guided imagery intervention and approximately 30 minutes after the intervention.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07860385, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.