StressNCT04515381
Title: Effect of Therapeutic Touch on Daytime Sleepiness, Stress and Fatigue
A study testing Therapeutic Touch in people with Stress and Fatigue, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among the students of nursing and midwifery. Design: Randomized placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Fatigue, Sleepiness
- What is being tested?
- Therapeutic Touch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2018to 15 Jun 2018
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- students who were at and above the age of 18,
- were the 1st year, 2nd year, 3rd year or 4th year students of nursing or midwifery,
- did not receive any energy therapy (Reiki, healing touch, therapeutic touch),
- received a score above 10 from the Epworth sleepiness scale (ESS),
- did not have any communication problem,
- and accepted to take part in the study were included in the study.
Who cannot join
- Students who were getting a psychologic and/or pharmacologic treatment in regard to their sleep, fatigue and stress problems,
- previously got a psychiatric diagnosis, still had a psychiatric illness,
- previously or still used anxiety (psychotropic) medicines were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mardin Artuklu University Of Scientific Research Projects
Objective: This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among the students of nursing and midwifery.
Design: Randomized placebo-controlled study.
Read the detailed description
The trial was conducted between April and July 2018. The students who met the inclusion criteria were separated into three groups through randomization method as in therapeutic touch (n=32), placebo (n=32) and control (n=32), and a total of 96 students participated in the study. In this randomized placebo controlled study, the therapeutic touch group were subjected to therapeutic touch for twice a week throughout 4 weeks with each session of 20 minutes. The data was acquired via Student Information Form, Epworth Sleepiness Scale, Pittburgh Sleep Quality Index, Perceived Stress Scale and Visual Analogue Scale for Fatigue.
- Conditions
- Stress, Fatigue, Sleepiness
- Being tested
- Therapeutic Touch, Control group, Sham Therapeutic Touch
- Keywords
- Therapeutic touch, Daytime sleepiness, Sleep quality, Stress, Fatigue, Nurse-midwifery student
- Medical subject headings
- Fatigue, Sleepiness, Disorders of Excessive Somnolence, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic TouchOther
Therapeutic Touch
Control groupOther
Making measurements at the beginning of the research and 4 weeks
Sham Therapeutic TouchOther
Sham Therapeutic Touch
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic touch group | Experimental | Each student from the Therapeutic touch (TT) group was given TT sessions via Krieger-Kunz method in a total of 8 times in the manner of twice a week for one group (Monday - Wednesday) and another group (Tuesday - Thursday) for a duration of 1 month (4 week). TT application procedure: The procedure was explained to the student, the student person was concentrated, concentrated practitioner for TT application, the student's entire body was evaluated from head to foot with the practitioner's hands at a distance of about 2 inc, hands were moved regularly and rhythmically to prevent imbalances in the energy field, the energy field was re-evaluated from top to bottom and rebalanced if there was a blocked area, finally, the student was left to rest and response to the treatment was observed. The TT sessions of 20 minutes were applied on the students and they were given a short rest at the end of the session Receives: Other: Therapeutic Touch |
| Placebo group | Placebo comparator | For students in the placebo group, the similar duration (20 minutes) and frequency (2 sessions a week, total of 8 sessions) of TT was applied with hands at a certain distance from the body (approximately 5 cm) and they were moved without a specific order. The application was performed by the other researcher in a separate room to the placebo group. Receives: Other: Sham Therapeutic Touch |
| Control group | Other | There was no attempt being made towards the students within the control group. At the end of the 4th week, all students were asked to repeat measurements Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale
The score of PSS-10 varied from 0 to 40. High score shows the excessiveness of the perceived stress of the individual
Measured: Change from baseline and 4 weeks.
Change in Epworth Sleepiness Scale
The scale consists of 8 items and score varies from 0-24. If the total score is between 2-10, it is considered as normal, pathological sleepiness indicator is greater than 10, thirteen and higher values are considered excessive daytime sleepiness.
Measured: Change from baseline and 4 weeks.
Change in Pittsburgh Sleep Quality Index
In PSQI analysis, 18 items were scored and there are 7 categories as in subjective sleep quality, delayed sleep, sleep duration, accustomed sleep activity, sleep disorder, use of sleeping pill and daytime dysfunction. Total score varies from 0 to 21. If the total PSQI score is ≤5, it stands for "good sleep quality", and if the score is >5, it stands for "bad sleep quality"
Measured: Change from baseline and 4 weeks.
Change in Visual Analogue Scale
The scale of fatigue is a scale of 10 cm that assesses the severity of the fatigue in the last week. The left side of the scale contains the label of "I do not feel fatigue", while the right side of the scale contains the label of "I Feel Extreme Fatigue and Exhaustion". VASF value is determined through the measurement of the distance between the very left side of the scale and the marked point
Measured: Change from baseline and 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start20 Apr 2018
- Primary completion1 May 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgül Vural Doğru, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515381
- Sponsor's protocol ID
- MAU.SRP.SH.005
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- 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 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mardin Artuklu University Of Scientific Research Projects
- ClinicalTrials.gov ID
- NCT04515381
- Acronym / sponsor ID
- MAU.SRP.SH.005
- Conditions
- Stress, Fatigue, Sleepiness
- Keywords
- Therapeutic touch, Daytime sleepiness, Sleep quality, Stress, Fatigue, Nurse-midwifery student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 17 Aug 2020 (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.
Objective: This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among the students of nursing and midwifery.
Design: Randomized placebo-controlled study.
Detailed description
The trial was conducted between April and July 2018. The students who met the inclusion criteria were separated into three groups through randomization method as in therapeutic touch (n=32), placebo (n=32) and control (n=32), and a total of 96 students participated in the study. In this randomized placebo controlled study, the therapeutic touch group were subjected to therapeutic touch for twice a week throughout 4 weeks with each session of 20 minutes. The data was acquired via Student Information Form, Epworth Sleepiness Scale, Pittburgh Sleep Quality Index, Perceived Stress Scale and Visual Analogue Scale for Fatigue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapeutic touch group | Experimental | Other: Therapeutic TouchEach student from the Therapeutic touch (TT) group was given TT sessions via Krieger-Kunz method in a total of 8 times in the manner of twice a week for one group (Monday - Wednesday) and another group (Tuesday - Thursday) for a duration of 1 month (4 week). TT application procedure: The procedure was explained to the student, the student person was concentrated, concentrated practitioner for TT application, the student's entire body was evaluated from head to foot with the practitioner's hands at a distance of about 2 inc, hands were moved regularly and rhythmically to prevent imbalances in the energy field, the energy field was re-evaluated from top to bottom and rebalanced if there was a blocked area, finally, the student was left to rest and response to the treatment was observed. The TT sessions of 20 minutes were applied on the students and they were given a short rest at the end of the session |
| Placebo group | Placebo comparator | Other: Sham Therapeutic TouchFor students in the placebo group, the similar duration (20 minutes) and frequency (2 sessions a week, total of 8 sessions) of TT was applied with hands at a certain distance from the body (approximately 5 cm) and they were moved without a specific order. The application was performed by the other researcher in a separate room to the placebo group. |
| Control group | Other | Other: Control groupThere was no attempt being made towards the students within the control group. At the end of the 4th week, all students were asked to repeat measurements |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- students who were at and above the age of 18,
- were the 1st year, 2nd year, 3rd year or 4th year students of nursing or midwifery,
- did not receive any energy therapy (Reiki, healing touch, therapeutic touch),
- received a score above 10 from the Epworth sleepiness scale (ESS),
- did not have any communication problem,
Key exclusion criteria (3 listed)
- Students who were getting a psychologic and/or pharmacologic treatment in regard to their sleep, fatigue and stress problems,
- previously got a psychiatric diagnosis, still had a psychiatric illness,
- previously or still used anxiety (psychotropic) medicines were excluded from the study.
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 |
|---|---|---|
| Therapeutic TouchTherapeutic Touch | Other | Therapeutic touch group |
| Control groupMaking measurements at the beginning of the research and 4 weeks | Other | Control group |
| Sham Therapeutic TouchSham Therapeutic Touch | Other | Placebo group |
Primary outcome
Change in Perceived Stress Scale
Time frame: Change from baseline and 4 weeks.
The score of PSS-10 varied from 0 to 40. High score shows the excessiveness of the perceived stress of the individual
Change in Epworth Sleepiness Scale
Time frame: Change from baseline and 4 weeks.
The scale consists of 8 items and score varies from 0-24. If the total score is between 2-10, it is considered as normal, pathological sleepiness indicator is greater than 10, thirteen and higher values are considered excessive daytime sleepiness.
Change in Pittsburgh Sleep Quality Index
Time frame: Change from baseline and 4 weeks.
In PSQI analysis, 18 items were scored and there are 7 categories as in subjective sleep quality, delayed sleep, sleep duration, accustomed sleep activity, sleep disorder, use of sleeping pill and daytime dysfunction. Total score varies from 0 to 21. If the total PSQI score is ≤5, it stands for "good sleep quality", and if the score is >5, it stands for "bad sleep quality"
Change in Visual Analogue Scale
Time frame: Change from baseline and 4 weeks.
The scale of fatigue is a scale of 10 cm that assesses the severity of the fatigue in the last week. The left side of the scale contains the label of "I do not feel fatigue", while the right side of the scale contains the label of "I Feel Extreme Fatigue and Exhaustion". VASF value is determined through the measurement of the distance between the very left side of the scale and the marked point
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 18 Aug 2020.
- 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 Therapeutic Touch in people with Stress and Fatigue, run by Mardin Artuklu 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 3 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 18 Aug 2020. 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. Some participants in this study may receive a placebo. 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 Perceived Stress Scale (time frame: Change from baseline and 4 weeks.). The study lists 4 primary outcomes in all. 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 18 Aug 2020.