Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT04923061
Status:
UNKNOWN
Last Update Posted:
2022-04-06
First Post:
2021-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Acupressure on the Sleep Quality and Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019050', 'term': 'Acupressure'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'As a result of the draw, group A was determined as acupressure and group B as sham acupressure group. Information showing that the nurses included in the research sample were assigned to groups A and B according to the randomization table will be placed in an opaque envelope. This envelope will be kept by the coordinator researcher (MG) and when the researcher with acupressure practice certificate (EC) goes to the nurse for the application, fills out the "Informed Consent Form" and opens the envelope to find out which group the nurse is in. Since all nurses included in the study will be taught to apply pressure to the pressure point, the participants will be blinded as the nurses do not know whether acupressure or sham acupressure is applied. The researcher (EC) cannot be blinded due to the nature of the research.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, parallel, two-arm, randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2021-06-05', 'studyFirstSubmitQcDate': '2021-06-05', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep quality evaluated using the Pittsburgh Quality Sleep Index', 'timeFrame': 'Change from before implementation and 4th week of practice.', 'description': 'The total scale score is in the range of 0 (minimum) -21 (maximum), and the high total Pittsburgh Quality Sleep Index (PSQI) score indicates that sleep quality is low. A total PSQI score between 0-4 indicates good sleep quality, while between 5-21 shows that sleep quality is low.'}], 'secondaryOutcomes': [{'measure': 'Fatigue evaluated using the Fatigue Severity Scale', 'timeFrame': 'Change from before implementation and 4th week of practice', 'description': 'It is a Likert-type scale consisting of a total of nine items, each item being evaluated between 1 and 7 (1=I totally disagree, 7=I totally agree). The fatigue score is obtained by dividing the total score obtained from the scale by the number of scale items. The score that can be obtained from the scale varies between 9 and 63. A high score indicates an increased level of fatigue.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupressure', 'Sham acupressure', 'Nurse', 'Sleep quality', 'Fatigue'], 'conditions': ['Sleep', 'Fatigue']}, 'descriptionModule': {'briefSummary': 'This research aims to determine the effect of acupressure applied to nurses actively working in internal clinics on sleep quality and fatigue during the COVID-19 pandemic process. This research hypothesizes that acupressure improves sleep quality and reduces fatigue.', 'detailedDescription': 'In this study, 68 nurses working in internal clinics were randomly assigned to acupressure and placebo (sham) acupressure groups. In the acupressure group (n=34), the heart meridian 7th point (HT7), large intestine meridian 4th point (LI4), stomach meridian 36th point (ST36) and spleen meridian 6th point (SP6) will be applied to a total of four points. Depending on the preparation and compression time on each point, the session duration of each nurse will be 20 minutes on average. In the sham group (n=34), pressure will be made approximately 1-1.5 cm away from the HT7, LI4, ST36, SP6 points. In the Sham group, the acupressure application time will take 20 minutes on average. Reminder text messages (SMS) will be sent before the application on the days when the nurses will practice, so that they continue to do the application regularly. At the end of the application, after the data collection process is completed, the sham group will be taught the correct acupressure points. Nurses will apply acupressure three times a week for a total of 12 sessions for four weeks. The primary outcome of the research is the effect of acupressure on the sleep quality of nurses. The secondary outcome of the study is to determine the effect of acupressure on fatigue. The outcomes will be collected before and four weeks after the acupressure and sham acupressure administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNurses who care for COVID 19 patients during the pandemic process\n\nNurses working in internal clinics during the data collection process\n\nThose who have recovered from COVID 19\n\nThose who agreed to participate in the study\n\nNo deformity or lesions in the areas where acupressure will be applied\n\nNo acupressure experience\n\nNo sleep disorder diagnosis and no medical treatment\n\nNot diagnosed with anxiety disorder and not receiving medical treatment\n\nNot diagnosed with depression and not receiving medical treatment\n\nCoffee, cigarette and alcohol free\n\nNo mental disorder\n\nNight shift workers\n\nThose who can understand and speak Turkish\n\nThose who signed the Informed Consent Form\n\nExclusion Criteria:\n\nNurses who did not work in internal clinics during the data collection process\n\nNurses who do not care for COVID 19 patients during the pandemic process\n\nThose with active COVID 19\n\nThose who do not agree to participate in the study\n\nThose who have any deformity or lesion in the areas where acupressure will be applied\n\nExperiences of acupressure\n\nHeart and kidney failure, severe anemia, immunodeficiency problem\n\nPregnant\n\nDiagnosed with sleep disorder and receiving treatment\n\nAnxiety disorder and treatment\n\nDepression diagnosed and treated\n\nCoffee, cigarette and alcohol addiction\n\nHaving mental illness\n\nFixed day shift workers\n\nThose who can not understand and speak Turkish\n\nThose who did not sign the Informed Consent Form'}, 'identificationModule': {'nctId': 'NCT04923061', 'briefTitle': 'The Effect of Acupressure on the Sleep Quality and Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': 'The Effect of Acupressure on Sleep Quality and Fatigue in Nurses Working in Internal Clinics During the COVID-19 Pandemic Process: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'MersinUniversityNursing'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupressure group', 'description': 'The experimental group will apply acupressure to themselves three times a week for a total of 12 sessions for four weeks.', 'interventionNames': ['Other: Acupressure']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham acupressure group', 'description': 'The sham group will apply acupressure to themselves three times a week for a total of 12 sessions for four weeks.', 'interventionNames': ['Other: Sham acupressure group']}], 'interventions': [{'name': 'Acupressure', 'type': 'OTHER', 'description': "In the acupressure group, heart meridian 7th point (HT7), large intestine meridian 4th point, stomach meridian 36th point (ST36) and spleen meridian 6th point (SP6) will be applied. Tissue sensitivity will be reduced by heating and rubbing for about 20 seconds without direct pressure on the acupressure points, and the points will be ready for acupressure application. Subsequently, consecutive (breathing rhythm) compressions will be applied to the acupressure points determined by the researcher, without raising the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief Since the symmetry of the selected four different points will also be applied to the other extremity, a total of 16 minutes of compression will be applied to each point, provided that it is two minutes. Each nurse's session will be approximately 20 minutes, depending on the preparation and compression time on each point.", 'armGroupLabels': ['Acupressure group']}, {'name': 'Sham acupressure group', 'type': 'OTHER', 'description': 'In the sham group, acupressure will be applied on the bone region where the meridians do not pass, approximately 1-1.5 cm away from the HT7, LI4, ST36, SP6 points. The application process will continue in the same way with acupressure group and the pressure intensity will be less.', 'armGroupLabels': ['Sham acupressure group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33343', 'city': 'Mersin', 'state': 'Yenişehir', 'country': 'Turkey (Türkiye)', 'facility': 'Mersin University', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'overallOfficials': [{'name': 'Meral Gun, Doctorate', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mersin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mersin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Esra Cavusoglu', 'investigatorAffiliation': 'Mersin University'}}}}