SurgeryNCT06502132
Comparison of the Effects of Therapeutic Touch and Patient Education on Postponed Patients
A study testing Patient Education Group and Therapeutic Touch Group in people with Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of therapeutic touch and patient education on anxiety, pain, satisfaction levels and physiological parameters of patients and to determine patient experiences. The study will be conducted as a mixed method study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery
- What is being tested?
- Patient Education Group and Therapeutic Touch Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2024to 27 Dec 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or olde
- To undergo surgery
- Postponement of the operation for 24 hours
- Being able to read, write and communicate in Turkish
- Not having any vision, hearing or speech problems
- Volunteering to participate in the study
Who cannot join
- Being under 18 years of age
- Complete cancellation of the operation
- Postponing the operation for more than 24 hours
- Having vision, hearing or speech problems that prevent communication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Health Sciences Institute
Erzurum, Yakutiye, 25030
About this study
Official title: Comparison of the Effects of Therapeutic Touch and Patient Education on Postponed
The aim of this study is to examine the effect of therapeutic touch and patient education on anxiety, pain, satisfaction levels and physiological parameters of patients and to determine patient experiences. The study will be conducted as a mixed method study. In the study, the effects of therapeutic touch and patient education on anxiety, satisfaction, pain levels and physiological parameters will be compared and the results will be compared. At the same time, qualitative statements of patients will be analyzed in depth and quantitative data will be supported.
Read the detailed description
The study will be conducted with a nested design mixed method in which qualitative and quantitative methods will be used together with two experimental groups (education and therapeutic touch) and one control group. For the quantitative part, patients who meet the inclusion criteria will be randomized into the experimental and control groups. For randomization, two main groups will be formed as "major" and "minor" according to the degree of operation. The names of these two main groups will be written on two fans. Then both "major" and "minor" groups will be divided into "therapeutic touch group", "patient education group" and "control group". This separation will be done by writing the names of the subgroups on small pieces of paper, and when there is a patient whose surgery is postponed, after determining which main group the patient belongs to according to the degree of operation, a paper will be randomly drawn from the fan by the researcher, and the patient will be admitted to that group according to the subgroup name written on the paper. Only one of the patients lying in the same room will be included in the study to avoid interference. In addition, data will be collected from the patients assigned to all three groups as a result of randomization by using the phenomenological approach method, one of the qualitative research designs, using the face-to-face interview technique. In addition, data will be collected from the patients assigned to all three groups as a result of randomization by using face-to-face interview technique with the phenomenological approach method, one of the qualitative research designs. It is planned to collect qualitative and quantitative data from the same sample. Before collecting the data, the patients will be informed about the study, their written consent will be obtained verbally and digitally with the informed consent form, and then the 21-question Descriptive Characteristics Form will be applied as a conversation with verbal communication method. This process will contribute to the development of communication. Afterwards, the "State-Trait Anxiety Scale" will be applied to the patients in all groups, and qualitative data will be collected from the patients by applying the "Semi-structured Interview Form Before Interventions" prepared by the researcher in addition to the therapeutic touch and patient information groups. Afterwards, the relevant interventions (therapeutic touch or patient education) will be applied to the experimental groups. After the interventions are applied, the patients will be given one hour to rest. Afterwards, the state part of the "State-Trait Anxiety Scale", the "Numerical Proportioning Scale", the "Physiological Parameters Assessment Form" and the "Patient Satisfaction Assessment Form According to Watson Improvement Processes" will be applied to all groups as a post-test. In addition to the experimental groups, the "Semi-structured Interview Form After Interventions" prepared by the researcher will be administered.
Hypotheses of the Research:
H1: Patient education has a positive effect on anxiety in surgical patients whose operations have been postponed.
H2: Patient education has a positive effect on patient satisfaction in surgical patients whose operations have been postponed.
H3: Patient education has a positive effect on pain in surgical patients whose operations have been postponed.
H4: Patient education has a positive effect on physiological parameters in surgical patients whose operations have been postponed.
H5: Therapeutic touch has a positive effect on anxiety in surgical patients whose operations have been postponed.
H6: Therapeutic touch has a positive effect on patient satisfaction in surgical patients whose operations have been postponed.
H7: Therapeutic touch has a positive effect on pain in surgical patients whose operations have been postponed.
H8: Therapeutic touch has a positive effect on physiological parameters in surgical patients whose operations have been postponed Mixed Methods Research Question: How do the findings obtained through quantitative methods regarding the postponement process in surgical patients whose operations have been postponed correspond to the individual interview data conducted to explore the patients' feelings, thoughts, and experiences regarding the postponement process?
Qualitative Research Method Questions:
- What are the feelings and thoughts of surgical patients whose operations have been postponed regarding the postponement situation? 2) What are the experiences of surgical patients whose operations have been postponed regarding the waiting process? 3) What is the relationship between the postponement of the operation and the anxiety, pain and satisfaction levels of the patients in surgical patients whose operations have been postponed? 4) What are the feelings and thoughts of surgical patients whose operations have been postponed regarding the interventions applied during the waiting process? 5) What are the experiences of surgical patients whose operations have been postponed regarding the interventions applied during the waiting process? 6) What are the expectations of surgical patients whose operations have been postponed from physicians and nurses during the waiting process? The study was planned to be conducted with 78 patients as a result of the power analysis test.
- Conditions
- Surgery
- Being tested
- Patient Education Group, Therapeutic Touch Group
- Keywords
- surgery, postponement, anxiety, pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Education GroupOther
Patients whose surgery has been postponed will be educated by the researcher through a booklet regarding the waiting process. The education includes information such as anxiety management, pain management, and re-surgery planning. The booklet consists of 22 pages and a copy is given to each patient in this group. The education lasts between 15-20 minutes and the patients' questions are answered. It is applied in a single session.
Therapeutic Touch GroupOther
Therapeutic touch application is applied as a single session and lasts approximately 20-25 minutes. The therapeutic touch that emerges from the artistic aspect of nursing is an energybased practice that does not involve physical contact. Therapeutic touch is a conscious and compassionate effort to direct the flow of one's universal life energy to healing by influencing this energy.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control group patients will receive routine care and no other intervention will be made within the scope of the study. |
| Patient Education Group | Active comparator | The patient education group will be informed about the waiting process that occurs as a result of surgery postponement through an education booklet prepared by the researcher in line with the literature. Receives: Other: Patient Education Group |
| Therapeutic Touch Group | Active comparator | During the waiting period, patients will receive therapeutic touch by a certified researcher. Receives: Other: Therapeutic Touch Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory (STAI-TX)
The 4-point Likert-type scale consists of two sections, each with 20 questions. The total score that can be obtained from the scale varies between 20 and 80, with a low average score indicating low anxiety and a high average score indicating high anxiety. There are ten reverse items in the State Anxiety Scale (1st, 2nd, 5th, 8th, 20th, 22nd, 25th, 26th, 19th and 20th), and seven reverse items in the Trait Anxiety Scale (21st, 26th, 37th, 30th, 33rd, 36th and 39th). The total score is calculated by subtracting the total weighted score of the reverse items from the total weighted score obtained for the direct items.
Measured: pre-test: 10 min;post-test: 5 min
Secondary outcomes (2)
Numeric Rating Scale (NRS)
This scale, which is used to determine the intensity of pain, requires the patient to describe their pain in numbers. The NRS is a one-dimensional scale consisting of a horizontal line with the words "0 = No pain" on one side and "10 = Unbearable pain" on the other side to measure the level of pain. The score marked by the patient on the scale indicates the level of pain. The higher the marked score, the more severe the pain level becomes. The NRS has been proven to be a valid and reliable measurement tool in determining the intensity of acute pain after surgery in adult and elderly patients and is widely used in clinical and research areas.
Measured: Pre-test: Administered when the patient is informed about the postponement of the surgery (5 seconds for the patient to answer). Post-test: administered again 1 hour after the pre-test is completed (patient responds in 5 seconds).
Patient Satisfaction Evaluation Form According to Watson Improvement Processes
The first five questions consist of seven-point Likert-type questions scored between 1 and 7. "1" is never, "7" is always, and the sixth question is answered with "Yes-No." The seventh question consists of an open-ended question that evaluates the "moments of care application" in the applied nursing care.
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start3 Jul 2024
- Primary completion5 Aug 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Three groups with two experimental groups and one control group, including patient education and therapeutic touch
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Gunay Uyar, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502132
- Sponsor's protocol ID
- AtaturkU-SBE-MGU-01
- Status last verified
- Feb 2025
- First submitted
- 5 Jul 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Therapeutic Touch and Patient Education on Postponed
- ClinicalTrials.gov ID
- NCT06502132
- Acronym / sponsor ID
- AtaturkU-SBE-MGU-01
- Conditions
- Surgery
- Keywords
- surgery, postponement, anxiety, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 16 Jul 2024 (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.
The aim of this study is to examine the effect of therapeutic touch and patient education on anxiety, pain, satisfaction levels and physiological parameters of patients and to determine patient experiences. The study will be conducted as a mixed method study. In the study, the effects of therapeutic touch and patient education on anxiety, satisfaction, pain levels and physiological parameters will be compared and the results will be compared. At the same time, qualitative statements of patients will be analyzed in depth and quantitative data will be supported.
Detailed description
The study will be conducted with a nested design mixed method in which qualitative and quantitative methods will be used together with two experimental groups (education and therapeutic touch) and one control group. For the quantitative part, patients who meet the inclusion criteria will be randomized into the experimental and control groups. For randomization, two main groups will be formed as "major" and "minor" according to the degree of operation. The names of these two main groups will be written on two fans. Then both "major" and "minor" groups will be divided into "therapeutic touch group", "patient education group" and "control group". This separation will be done by writing the names of the subgroups on small pieces of paper, and when there is a patient whose surgery is postponed, after determining which main group the patient belongs to according to the degree of operation, a paper will be randomly drawn from the fan by the researcher, and the patient will be admitted to that group according to the subgroup name written on the paper. Only one of the patients lying in the same room will be included in the study to avoid interference. In addition, data will be collected from the patients assigned to all three groups as a result of randomization by using the phenomenological approach method, one of the qualitative research designs, using the face-to-face interview technique. In addition, data will be collected from the patients assigned to all three groups as a result of randomization by using face-to-face interview technique with the phenomenological approach method, one of the qualitative research designs. It is planned to collect qualitative and quantitative data from the same sample. Before collecting the data, the patients will be informed about the study, their written consent will be obtained verbally and digitally with the informed consent form, and then the 21-question Descriptive Characteristics Form will be applied as a conversation with verbal communication method. This process will contribute to the development of communication. Afterwards, the "State-Trait Anxiety Scale" will be applied to the patients in all groups, and qualitative data will be collected from the patients by applying the "Semi-structured Interview Form Before Interventions" prepared by the researcher in addition to the therapeutic touch and patient information groups. Afterwards, the relevant interventions (therapeutic touch or patient education) will be applied to the experimental groups. After the interventions are applied, the patients will be given one hour to rest. Afterwards, the state part of the "State-Trait Anxiety Scale", the "Numerical Proportioning Scale", the "Physiological Parameters Assessment Form" and the "Patient Satisfaction Assessment Form According to Watson Improvement Processes" will be applied to all groups as a post-test. In addition to the experimental groups, the "Semi-structured Interview Form After Interventions" prepared by the researcher will be administered.
Hypotheses of the Research:
H1: Patient education has a positive effect on anxiety in surgical patients whose operations have been postponed.
H2: Patient education has a positive effect on patient satisfaction in surgical patients whose operations have been postponed.
H3: Patient education has a positive effect on pain in surgical patients whose operations have been postponed.
H4: Patient education has a positive effect on physiological parameters in surgical patients whose operations have been postponed.
H5: Therapeutic touch has a positive effect on anxiety in surgical patients whose operations have been postponed.
H6: Therapeutic touch has a positive effect on patient satisfaction in surgical patients whose operations have been postponed.
H7: Therapeutic touch has a positive effect on pain in surgical patients whose operations have been postponed.
H8: Therapeutic touch has a positive effect on physiological parameters in surgical patients whose operations have been postponed Mixed Methods Research Question: How do the findings obtained through quantitative methods regarding the postponement process in surgical patients whose operations have been postponed correspond to the individual interview data conducted to explore the patients' feelings, thoughts, and experiences regarding the postponement process?
Qualitative Research Method Questions:
- What are the feelings and thoughts of surgical patients whose operations have been postponed regarding the postponement situation? 2) What are the experiences of surgical patients whose operations have been postponed regarding the waiting process? 3) What is the relationship between the postponement of the operation and the anxiety, pain and satisfaction levels of the patients in surgical patients whose operations have been postponed? 4) What are the feelings and thoughts of surgical patients whose operations have been postponed regarding the interventions applied during the waiting process? 5) What are the experiences of surgical patients whose operations have been postponed regarding the interventions applied during the waiting process? 6) What are the expectations of surgical patients whose operations have been postponed from physicians and nurses during the waiting process? The study was planned to be conducted with 78 patients as a result of the power analysis test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three groups with two experimental groups and one control group, including patient education and therapeutic touch
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control group patients will receive routine care and no other intervention will be made within the scope of the study. |
| Patient Education Group | Active comparator | Other: Patient Education GroupThe patient education group will be informed about the waiting process that occurs as a result of surgery postponement through an education booklet prepared by the researcher in line with the literature. |
| Therapeutic Touch Group | Active comparator | Other: Therapeutic Touch GroupDuring the waiting period, patients will receive therapeutic touch by a certified researcher. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 years of age or olde
- To undergo surgery
- Postponement of the operation for 24 hours
- Being able to read, write and communicate in Turkish
- Not having any vision, hearing or speech problems
Key exclusion criteria (4 listed)
- Being under 18 years of age
- Complete cancellation of the operation
- Postponing the operation for more than 24 hours
- Having vision, hearing or speech problems that prevent communication
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 |
|---|---|---|
| Patient Education GroupPatients whose surgery has been postponed will be educated by the researcher through a booklet regarding the waiting process. The education includes information such as anxiety management, pain management, and re-surgery planning. The booklet consists of 22 pages and a copy is given to each patient in this group. The education lasts between 15-20 minutes and the patients' questions are answered. It is applied in a single session. | Other | Patient Education Group |
| Therapeutic Touch GroupTherapeutic touch application is applied as a single session and lasts approximately 20-25 minutes. The therapeutic touch that emerges from the artistic aspect of nursing is an energybased practice that does not involve physical contact. Therapeutic touch is a conscious and compassionate effort to direct the flow of one's universal life energy to healing by influencing this energy. | Other | Therapeutic Touch Group |
Primary outcome
State-Trait Anxiety Inventory (STAI-TX)
Time frame: pre-test: 10 min;post-test: 5 min
The 4-point Likert-type scale consists of two sections, each with 20 questions. The total score that can be obtained from the scale varies between 20 and 80, with a low average score indicating low anxiety and a high average score indicating high anxiety. There are ten reverse items in the State Anxiety Scale (1st, 2nd, 5th, 8th, 20th, 22nd, 25th, 26th, 19th and 20th), and seven reverse items in the Trait Anxiety Scale (21st, 26th, 37th, 30th, 33rd, 36th and 39th). The total score is calculated by subtracting the total weighted score of the reverse items from the total weighted score obtained for the direct items.
2 secondary outcomes
Numeric Rating Scale (NRS)
Time frame: Pre-test: Administered when the patient is informed about the postponement of the surgery (5 seconds for the patient to answer). Post-test: administered again 1 hour after the pre-test is completed (patient responds in 5 seconds).
Patient Satisfaction Evaluation Form According to Watson Improvement Processes
Time frame: 5 min
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 5 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education Group and Therapeutic Touch Group in people with Surgery, run by Ataturk 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 6 inclusion and 4 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 5 Feb 2025. 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?
State-Trait Anxiety Inventory (STAI-TX) (time frame: pre-test: 10 min;post-test: 5 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2025.